Search Results
within category "Lung & Respiratory"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal
therapy for the treatment of refractory IPA
Alexander Lepak, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05238116
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Inclusion Criteria:
1. Participant has proven or probable IPA according to the modified 2019 European
Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and
Research Consortium (EORTC/MSGERC) consensus definitions or according to the 2010
International Society for Heart and Lung Transplantation (ISHLT) consensus statements
for the definitions of infections in cardiothoracic transplant recipients.
2. Participant's IPA has failed to respond to adequate antifungal therapy.
Exclusion Criteria:
1. Participant with a known or suspected concomitant medical condition or post-surgery
complication that, in the opinion of the Investigator, may jeopardize adherence to the
protocol requirements or impede the accurate measurement of efficacy or may be an
unacceptable additional risk to the Participant should he/she participate in the
study.
2. Participant who has previously received PC945.
3. Participant with a known history of allergy, hypersensitivity, or any previous serious
reaction to any component of the PC945 or placebo formulations.
4. Participant who has recently received, is receiving or due to receive at any time
during the study, an investigational medicinal agent that does not have any regulatory
approved indications. Subjects who are participating in any other trials e.g.,
Observational, diagnostic or using medications with an approved indication may be
allowed to participate after consultation with the sponsor on an individual basis
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of
vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis
(CF).
Hara Levy, MD
All
1 Year and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05844449
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Key
Inclusion Criteria:
• Participants who have completed study drug treatment in the parent study
(VX21-121-105; NCT Number: NCT05422222)
Key
Exclusion Criteria:
• Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe
hepatic impairment that might pose an additional risk in administering study drug
• History of solid organ, hematological transplantation, or cancer
• History of drug intolerance in the parent study
Other protocol defined Inclusion/Exclusion criteria may apply.
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors (FIT-001)
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in
adult patients with advanced solid tumors.
Justine Bruce, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT06026410
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Inclusion Criteria:
• At least 18 years of age.
• Histologically or cytologically confirmed advanced solid tumors
• Arm #1 (Monotherapy): HRAS-mutant and/or amplified tumors (any solid tumor type);
HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant
and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC
• Arm #2 (Combination): Must have received at least 1 prior systemic therapy with
IO-based treatment for locally advanced or metastatic RCC with predominantly
clear cell subtype
• Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic
NSCLC and have received at least 1 prior systemic therapy for advanced or
metastatic NSCLC
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Karnofsky Performance Status of 70 or higher with no clinically significant
deterioration over the previous 2 weeks.
• Acceptable liver, renal, endocrine, and hematologic function.
• Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
• Ongoing treatment with certain anticancer agents.
• Prior treatment with an FTI or HRAS inhibitor.
• Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1,
without complete recovery.
• Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
• Toxicity (excluding alopecia) from prior therapy that has not been completely resolved
to baseline at the time of consent.
• Active or prior documented autoimmune or inflammatory disorders within the past 5
years prior to Cycle 1 Day 1 (with exceptions).
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic
therapy.
• Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that
may significantly alter the absorption of the trial drugs.
• Inadequate cardiac and/or vascular function, including receipt of treatment for
unstable angina, myocardial infarction, and/or cerebro-vascular attack within the
prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.
• Other invasive malignancy within 2 years.
• Other protocol-defined exclusion criteria may apply.
Solid Tumors With HRAS Alterations, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Clear Cell Renal Cell Carcinoma (ccRCC), Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Sarcoma, Uterus
A Study of NDI 1150-101 in Patients With Solid Tumors
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose
(RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and
preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with
pembrolizumab in adult patients with advanced solid tumors.
Hamid Emamekhoo, M.D.
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05128487
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Key
Inclusion Criteria:
• Life expectancy of ≥ 12 weeks
• Measurable or non-measurable disease for Dose Escalation; measurable disease using
RECIST v1.1 is required for Dose Expansion
• Recovered from prior therapy to Grade ≤ 1 or return to baseline status (except for
alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients with adequate bone marrow, kidney and liver function
• Last dose of previous anticancer therapy ≥ 4 weeks prior to first dose of NDI-101150;
includes prior anti-PD-1 or anti-PD-L1 therapy, other anticancer therapy,
radiotherapy, or surgical intervention
• For Dose Escalation Phase Only (Dose Escalation, Monotherapy and Combination Therapy):
Histologically or cytologically confirmed advanced or metastatic solid tumors for whom
no standard therapies are available or refractory to standard therapy
• For Dose Expansion Phase (Dose Expansion, Monotherapy and Combination Therapy):
Willing to consent to required tumor biopsy(ies). Histologically or cytologically
confirmed advanced or metastatic G/GEJ, NSCLC or RCC for which no standard therapy is
available or are refractory to standard therapy
Key
Exclusion Criteria:
• Previous solid organ or hematopoietic cell transplant
• Central nervous system (CNS) malignant disease not previously treated, active
leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant
disease requiring steroid or other therapeutic intervention
• Prior anticancer therapy within 2-6 weeks of trial start (depending on nature of
therapy).
• Clinically significant cardiovascular disease
• History of severe hypersensitivity reaction to treatment with monoclonal antibody(ies)
(for combination therapy cohorts only)
• History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis
(including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans,
cryptogenic organizing pneumonia, etc.), or evidence of history of pneumonitis on
chest computed tomography scan in the last 6 months
• Known additional malignancy that is active and/or in progression requiring treatment
• Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function,
unstable pulmonary condition, uncontrolled diabetes, thromboembolic event within the
past 3 months) or any important medical or psychiatric illness or abnormal laboratory
finding
• Unable to discontinue medications that are strong inducers or inhibitors of CYP3A4
and/or CYP2C8
• History of severe irAE that led to permanent discontinuation of prior immunotherapy
• History of recent Grade >/= 3 irAE or any Grade 4 life-threatening irAE, neurologic or
ocular AE of any grade while receiving prior immunotherapy
NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Solid Tumor, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Sarcoma, Uterus
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
This is a randomized, open-label study of Serplulimab plus chemotherapy
(Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously
untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
- Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Toby Campbell, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05468489
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Inclusion Criteria:
Voluntary participation in clinical studies.
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans
Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to
randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1
expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy
for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study
drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study
based on the investigator's judgment.
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
This study is an open-label, international, multi-center, Phase 1 study in adult patients
with solid tumors likely to express CLDN18.2.
Nataliya Uboha, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05980416
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Key
Inclusion Criteria:
• Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
• Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as
gastric/GEJ, pancreatic and esophageal cancer
• ≥ 18 years of age
• ECOG performance status (PS) 0 or 1 at Screening
• Progressed on or after standard therapy, or are intolerable for available standard
therapy, or there is no available standard therapy
• Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
• Adequate organ function
• Life expectancy > 12 weeks
• Ability to understand the nature of this study, comply with protocol requirements, and
give written informed consent
• Willingness of men and women of reproductive potential to observe conventional and
effective birth control for the duration of treatment and for 3 months following study
completion
Key
Exclusion Criteria:
• Pregnant or breastfeeding
• Symptomatic or untreated brain metastases
• Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC
containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be
eligible)
• Have peripheral neuropathy Grade ≥2
• Have history of non-infectious pneumonitis/interstitial lung disease
• Have diagnosis of another malignancy, or history of systemic treatment for invasive
cancer within last 3 years. Note: Patients with Stage I cancer who have received
definitive local treatment and are considered unlikely to recur are eligible.
Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or
noninvasive tumor does not affect eligibility
• Have active ocular surface disease at baseline (based on screening ophthalmic
examination)
• Have serious concurrent illness or clinically relevant active bacterial, fungal or
viral infection
• Have previous hypersensitivity to any known components of EO-3021 or history of severe
infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal
antibody treatment
• Clinically significant cardiac disease, including but not limited to symptomatic
congestive heart failure, unstable angina, acute myocardial infarction within 6 months
of planned first dose, or unstable cardiac arrhythmia requiring therapy (including
torsades de pointes)
• Have history of allogenic hematopoietic stem cell transplantation or solid organ
transplantation with ongoing systemic immunosuppressive therapy
• Patients who are not appropriate candidates for participation in this clinical study
for any other reason as deemed by the Investigator
Pancreas Neoplasm, Stomach Neoplasm, Gastrointestinal Neoplasms, Digestive System Neoplasm, Neoplasms by Site, Neoplasms, Lip, Oral Cavity and Pharynx, Esophagus, Colon, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Melanoma, Skin, Kaposi's Sarcoma, Breast, Cervix, Corpus Uteri, Other Female Genital, Other Male Genital, Kidney, Eye and Orbit, Brain and Nervous System, Other Endocrine System, Ill-Defined Sites, Anal, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Ovary, Sarcoma, Uterus
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the safety, tolerability, and efficacy of
IDE161.
Mark Burkard, MD, PhD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05787587
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Inclusion Criteria:
1. Adult participants must be 18 years of age or older
2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS)
tumors
3. Have documented evidence of genetic alterations conferring homologous recombination
deficiency
4. Participant must have progressed on at least one prior line of therapy in the advanced
or metastatic setting that is considered an appropriate standard of care, or for which
the participant has documented intolerance
Exclusion Criteria:
1. Known primary CNS malignancy
2. Impairment of GI function or GI disease that may significantly alter the absorption of
IDE161
3. Have active, uncontrolled infection
4. Clinically significant cardiac abnormalities
5. Major surgery within 4 weeks prior to enrollment
6. Radiation therapy within 2 weeks prior to enrollment
7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
8. Radioimmunotherapy within 6 weeks of enrollment
9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks,
whichever is shorter
Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Mycosis Fungoides, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Anal, Bladder, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Melanoma/Skin cancer, Sarcoma, Uterus
This pilot comparative effectiveness trial will compare two active smoking cessation
treatments in terms of effectiveness, equity across patient subpopulations, and efficiency
among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment
comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a
cancer focus will be compared against an active comparator modeled after standard quitline
treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50
participants will be recruited to generate estimates of the effects, acceptability, costs,
and equity of enhanced treatment (vs. standard treatment), with the primary outcome being
abstinence from smoking 26 weeks after trying to quit.
Danielle Mccarthy
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT06218823
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Inclusion Criteria:
• Alive (per medical record)
• Diagnosed with cancer in the past 3 years
• Received care from a participating oncology clinic in the past year
• Has a current tobacco use status
• Does not have a preferred language other than English (missing language preference
will be included).
• Valid address that is not a correctional facility or residential treatment/care
facility.
• No flag for patient cognitive impairment, activated health care power of attorney, or
other health care agent (e.g., legally authorized representative) in the EHR.
The following additional inclusion criteria must be met for inclusion in the CET
• Smoked combustible cigarettes in the past month.
• Able to speak and understand English.
• Willing to set a date to quit smoking in the next 60 days.
• Willing to receive smoking treatment information.
• Willing to complete study activities.
Exclusion Criteria:
• No current suicidal ideation.
• Suicide attempt in the past year.
• Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective
disorder, or psychotic disorder.
• Incarceration.
• Unable to provide informed consent to treatment (i.e., cannot answer questions about
study procedures or risks after hearing about the study).
Smoking Cessation, Cancer, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Mycosis Fungoides, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Leukemia, other, Other Hematopoietic, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Leukemia, Lymphoma, Melanoma/Skin cancer, Sarcoma, Uterus
A Phase 1/2 Study of DCC-3116 in Patients With RAS/MAPK Pathway Mutant Solid Tumors
This is a Phase 1/2, multicenter, open label, first in human (FIH) study of DCC-3116 as
monotherapy, and in combination with trametinib, binimetinib, or sotorasib in patients with
advanced or metastatic solid tumors with RAS/MAPK pathway mutation. The study consists of 2
parts, a dose-escalation phase, and an expansion phase.
Nataliya Uboha, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04892017
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Inclusion Criteria:
1. Male or female participants ≥18 years of age
2. Dose Escalation Phase (Part 1):
Escalation Cohort B combination with trametinib and Cohort C combination with
binimetinib closed on January 8, 2024.
1. Participants must have a pathologically confirmed diagnosis of an advanced or
metastatic solid tumor with a documented RAS, NF1, or RAF mutations. A molecular
pathology report documenting mutational status of RAS, NF1, or RAF must be
available.
2. Progressed despite standard therapies, and received at least 1 prior line of
anticancer therapy.
• Participants with a documented mutation in BRAF V600E or V600K must have
received approved treatments known to provide clinical benefit prior to
study entry.
3. Participants enrolled in the DCC-3116 and sotorasib cohort (Cohort D) must have a
KRAS G12C mutation.
3. Dose Expansion Phase (Part 2):
Expansion Cohorts 1, 2, 3 and 4 combinations will not open for enrollment.
Cohort 5: Patients with KRAS G12C mutant NSCLC
• Pathologically confirmed NSCLC with a documented mutation in KRAS G12C.
• Received at least 1 prior line but no more than 3 prior lines of systemic therapy
in the advanced or metastatic setting.
• Have not received prior sotorasib or other KRAS G12C inhibitor therapy.
4. Must provide a fresh tumor biopsy from a primary or metastatic cancer lesion that can
be biopsied with acceptable risk as determined by the Investigator, and archival tumor
tissue sample, if available. If a fresh tumor biopsy is not possible, then an archival
tumor tissue sample must be provided.
5. Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 (Dose Escalation) or 0 to 1
(Dose Expansion) at Screening
6. Adequate organ function and bone marrow function.
7. If a female of childbearing potential must have a negative pregnancy test prior to
enrollment and agree to follow the contraception requirements.
8. Male participants must agree to follow contraception requirements.
9. Must provide signed consent to participate in the study and is willing to comply with
study-specific procedures.
Exclusion Criteria:
1. Must not have received the following within the specified time periods prior to the
first dose of study drug:
1. Prior therapies (anticancer or therapies given for other reasons) that are known
strong or moderate inhibitors or inducers of CYP3A4 or P-gp including certain
herbal medications (e.g., St. John's Wort): 14 days or 5× the half-life of the
medication (whichever is longer)
2. All other prior anticancer therapies or any therapy that is investigational for
the participant's condition with a known safety and PK profile: 14 days or 5× the
half-life of the medication (whichever is shorter)
3. Investigational therapies with unknown safety and PK profile: 28 days. If there
is enough data on the investigational therapy to assess the risk for drug-drug
interactions and late toxicities of prior therapy as low, the Sponsor's Medical
Monitor may approve a shorter washout of 14 days
4. Grapefruit or grapefruit juice: 14 days
2. Have not recovered from all toxicities from prior therapy according to National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
3. Presence or history of central nervous system (CNS) metastases or leptomeningeal
disease, with some exceptions
4. New York Heart Association Class III or IV heart disease, active ischemia, or any
other uncontrolled cardiac condition such as angina pectoris, clinically significant
cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart
failure, or myocardial infarction within 6 months prior to the first dose of study
drug.
5. Prolongation of the QT interval corrected by Fridericia's formula (QTcF) based on
repeated demonstration of QTcF >450 ms in males or >470 ms in females at screening, or
history of long QT syndrome.
6. Left ventricular ejection fraction (LVEF) <50% at Screening
7. Systemic arterial thrombotic or embolic events within 6 months prior to the first dose
of study drug
8. Systemic venous thrombotic events within 1 month prior to the first dose of study drug
9. Malabsorption syndrome
10. Bone disease that requires ongoing treatment or has required treatment.
11. Major surgery within 4 weeks of the first dose of study drug. All surgical wounds must
be healed and free of infection or dehiscence before the first dose of the study drug.
12. Any other clinically significant comorbidities.
13. For participants receiving DCC-3116 and trametinib combination or DCC-3116 and
binimetinib combination: previous treatment with trametinib or binimetinib that
resulted in treatment discontinuation due to intolerability as a result of an adverse
event (AE) that was considered related to trametinib or binimetinib.
14. For participants receiving DCC-3116 and sotorasib combination in Dose Escalation Part
1: previous treatment with sotorasib that resulted in treatment discontinuation due to
intolerability as a result of an adverse event (AE) that was considered related to
sotorasib.
15. For participants receiving DCC-3116 and sotorasib combination: Use of proton pump
inhibitors (PPIs) and H2 receptor antagonists that cannot be discontinued 3 days prior
to the start of study drug administration.
16. Known allergy or hypersensitivity to any component of the investigational drug
products.
17. Known human immunodeficiency virus unless the following requirements are met:
1. CD4 count >350/µL
2. No AIDS-defining opportunistic infection in the last 12 months
3. Stable anti-retroviral regimen with medications that are not prohibited by the
protocol for at least 4 weeks with HIV viral load less than 400 copies/mL prior
to enrollment.
18. Known active hepatitis B, active hepatitis C infection or if the participant is taking
medications that are prohibited per protocol.
19. If female, the participant is pregnant or lactating.
20. Ongoing participation in an interventional study.
21. For participants receiving DCC-3116 and binimetinib combination: Known Gilbert's
syndrome
Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Other Hematopoietic, Unknown Sites, Ill-Defined Sites, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Melanoma/Skin cancer, Sarcoma, Uterus, Non-Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Solid Tumor
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT)
to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by
immunotherapy with durvalumab) versus standard treatment alone in treating patients with
non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special
equipment to position a patient and deliver radiation to tumors with high precision. This
method may kill tumor cells with fewer doses over a shorter period and cause less damage to
normal tissue. IGRT is a type of radiation that uses a computer to create picture of the
tumor, to help guide the radiation beam during therapy, making it more accurate and causing
less damage to healthy tissue. Standard chemotherapy used in this trial consists of
combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and
etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It
works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of
medications known as platinum-containing compounds. It works in a way similar to the
anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by
killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of
medications called antimicrotubule agents. It works by stopping the growth and spread of
tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents.
It works by blocking the action of a certain substance in the body that may help tumor cells
multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It
blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells.
Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere
with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of
IGRT with chemotherapy and immunotherapy may be more effective at treating patients with
inoperable non-small cell lung cancer than giving the standard treatment alone.
Andrew Baschnagel, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05624996
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Inclusion Criteria:
• Pathologically (histologically or cytologically) proven diagnosis of stage II or III
(American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer
(NSCLC) with known PD-L1 status prior to registration
• Patients must have an identified primary tumor and at least one nodal metastasis
(peribronchial/hilar/intrapulmonary, mediastinal/subcarinal,
supraclavicular/scalene)
• Up to 4 cycles of systemic therapy received prior to registration for the current
study cancer is allowable; any prior chemotherapy for a different cancer is also
permissible
• The patient must be deemed clinically appropriate for curative intent definitive
combined modality therapy, based on the following staging assessments:
• History/physical examination prior to registration;
• Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the
brain (if available, contrast is preferred for all neuroimaging) prior to
registration;
• CT chest with IV contrast (if contrast is available and unless contraindicated,
such as for abnormal kidney function) prior to registration. PET/CT may be used
if the CT portion is of identical diagnostic quality as achieved in a stand-alone
CT
• No evidence of distant metastases based on FDG PET/CT scan obtain within 60 days of
registration
• Primary tumor =< 7 cm
• Age >= 18
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the
discretion of the treating physician, to allow for treatment with chemotherapy and
concurrent radiation therapy
• Creatinine clearance >= 25 mL/min by the Cockcroft-Gault (C-G) equation
• Subjects with non-malignant pleural effusion are eligible provided the effusion is not
known or demonstrated to be an exudative effusion
• If a pleural effusion is present, the following criteria must be met to exclude
malignant involvement:
• When pleural fluid is visible on both the CT scan and on a chest x-ray, a
pleuracentesis is required to confirm that the pleural fluid is
cytologically negative;
• Effusions that are minimal (i.e., not visible on chest x-ray) that are too
small to safely tap are eligible
• Medical history consistent with the patient being amenable, at the discretion of the
treating physician, to allow for treating with consolidation immunotherapy. Patients
with known EGFR/ALK mutation at the time of registration are eligible, and these
patients can be treated with consolidation durvalumab or chemotherapy at the
discretion of the treating physician
• Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen
• Negative pregnancy test =< 14 days prior to registration for participants of
childbearing potential
• The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
• Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields that is determined by the treating physician to impede the
treatment of the study malignancy
• Patients without identifiable primary tumor and at least 1 pathologically enlarged
lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1
radiographically-involved lymph node is required, but pathologic confirmation of
involvement is not mandated
• Centrally located primary tumor < 2 cm from involved nodal disease which would result
in significant overlap of the primary SBRT and nodal radiation fields. Centrally
located is defined as within or touching the zone of the proximal bronchial tree,
which is a volume 2 cm in all directions around the proximal bronchial tree (carina,
right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus,
right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi)
• Participants who are pregnant or unwilling to discontinue nursing
• Participants of childbearing potential (participants who may become pregnant or who
may impregnate a partner) unwilling to use highly effective contraceptives during
therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe
required after the final dose of the selected chemotherapy regimen, because the
treatment in this study may be significantly teratogenic
Lung, Locally Advanced Lung Non-Small Cell Carcinoma, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to
determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of
CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm
B) or Cetuximab (CFT1946 + cetuximab; Arm C).
Vincent Ma, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05668585
Show full eligibility criteria
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Inclusion Criteria:
1. Subject (or legally authorized representative, where applicable) is willing and able
to provide signed informed consent and can follow protocol requirements
2. Subject is ≥18 years of age at time of informed consent
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or
liquid biopsy: (other protocol conditions may apply)
5. Subject must have received ≥1 prior line of SoC therapy for their unresectable locally
advanced or metastatic disease with disease progression on or after last prior
treatment. Prior regimens for these subjects vary by indication and investigational
arm, but must have included the following:
1. Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF
inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior
(neo)adjuvant immunotherapy may be acceptable.
2. CRC: Subjects must have received no more than 4 lines of prior therapy which
includes systemic chemotherapy-based regimen per SoC for unresectable locally
advanced or metastatic disease, and previous treatment with BRAF inhibitor in
combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or
dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must
have received at least 2 prior treatments. Subjects who received neo(adjuvant)
chemotherapy regimens may be eligible.
3. ATC: Subjects must have received SoC therapy options including BRAF inhibitor if
available and of benefit to the subject
4. Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC
therapy options per their Investigator's best judgment, including BRAF inhibitor
if available and of benefit to the subject
6. Subject has measurable disease per RECIST v1.1
7. Adequate bone marrow, liver, renal, and cardiac function
8. A female subject may be eligible if not pregnant, planning a pregnancy, not breast
feeding, a women of non-child bearing potential or a WOCBP willing to comply with
protocol conditions relating to the use contraception, ova or blood donation and
pregnancy testing prior to the first dose
9. A male subject must agree to comply with protocol conditions relating to the use of
contraception, sperm and blood donation
10. Subject can safely swallow a tablet or pill
Other protocol defined exclusion criteria may apply
Exclusion Criteria:
1. Subject has had major surgery within 21 days prior to the planned first dose. Minor
surgery is permitted within 21 days prior to enrollment
2. Subject with CNS involvement (primary tumor or metastatic disease), except if
clinically stable, have no evidence of new or enlarging brain metastases and are on
stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects
with untreated brain metastases may be eligible to enter without prior radiation
therapy.
3. Subject with known malignancy other than trial indication that is progressing or has
required treatment within the past 3 years, except for conditions that have undergone
potentially curative therapy
4. Subject with history of thromboembolic or cerebrovascular events ≤6 months as defined
in the protocol
5. Subject with impaired cardiac function or clinically significant cardiac disease, as
defined in the protocol
6. Subject with history of uncontrolled diabetes mellitus (only for subjects who will
receive CFT1946 + trametinib)
7. Subject with history or current evidence of retinal vein occlusion (RVO),
chorioretinopathy, or current risk factors for RVO (only for subjects who will receive
CFT1946 + trametinib)
8. Subject has received live, attenuated vaccine within 28 days prior to first dose
administration
9. Subject has history of pneumonitis or interstitial lung disease
10. Subject has history of uveitis
11. Subject has clinically significant gastrointestinal abnormalities.
12. Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
13. Subject has history of or known HBV or active HCV infection
14. Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers,
including any herbal medications/supplements
15. Subject has presence of Grade ≥2 toxicity due to prior cancer therapy, excepting
alopecia and hypothyroidism requiring thyroid replacement therapy
16. Subject has initiation or receipt of the following ≤7 days prior to first dose
administration: Hematopoietic colony-stimulating growth factors, transfusion of packed
red blood cells (pRBC), and transfusion of platelets
17. Subject is pregnant, breastfeeding, or expecting to conceive or father children any
time during the study
Other protocol defined exclusion criteria may apply
Solid Tumors, Melanoma, NSCLC, CRC, ATC, Colon, Rectum, Lung, Melanoma, Skin, Thyroid, Colon and Rectum, Melanoma/Skin cancer
Comparison of Microglial Activation in Severe Asthma and Healthy Controls (MAIA-SC)
The goal of this clinical trial is to learn about how asthma influences brain function. The
main questions it aims to answer are:
- How airway inflammation in asthma affects the brain; and,
- Whether airway inflammation in asthma is related to symptoms of depression and anxiety
Over the course of 3 visits, participants will:
- Complete questionnaires
- Complete computer tasks
- Undergo allergy skin test and breathing tests
- Give two blood samples
- Give a sputum sample
- Complete brain imaging scans
Researchers will compare results between participants with asthma, and participants who do
not have asthma.
Melissa Rosenkranz, PhD
All
18 Years to 75 Years old
N/A
This study is also accepting healthy volunteers
NCT06299592
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Inclusion Criteria:
• Ability to understand and the willingness to sign a written informed consent document
• Individuals with no health concerns that might affect the outcome of the study
• Age 18-75 years of age
• Ability to tolerate a simulated MRI brain scanning session
• In the opinion of the investigator, capable and willing to grant written informed
consent and cooperate with study procedures and requirements
• High-affinity TSPO-binding genotype. Mixed (high/low) binding-affinity genotype may be
included at PIs discretion
• For participants with severe asthma:
• Physician diagnosis of asthma for at least six months prior to screening (can be
determined at the discretion of an asthma/allergy physician member of the study team)
• Severe asthmatics must meet the ATS definition of severe asthma and/or be currently
receiving a GINA 5 therapy or daily treatment of equal to or greater than 640mcg
Budesinide.
Exclusion Criteria:
• Current smoker (defined as more than 0.5 pack per week for the past 6 months and any
smoking within two weeks of study procedures) or has a smoking history exceeding 5
pack years within the last 10 years
• Currently receiving immunotherapy
• Use of psychotropic medication that might affect function of neurocircuitry implicated
in our hypotheses (at the discretion of the PI/Co-I)
• Inability to hold medications detailed in the medication hold schedule
• Needle phobia or claustrophobia
• Major health problems such any of the following in the last 6 months: stroke/TIA,
myocardial Infarction, stent placement, or acute coronary syndrome are definitively
exclusionary. Decisions regarding other major health problems, such as autoimmune
disease, history of carotid stenosis, heart disease, uncontrolled hypertension, lung
diseases other than asthma, history of significant arrhythmias, etc. will be based
upon the judgement of the PI/Co-I.
• Use of biologic medication that might affect signaling pathways under investigation
(at the discretion of the PI/Co-I)
• Pre-existing chronic infectious disease
• Scheduled use of non-selective beta-blockers prior to each study visit.
• Use of an investigational drug within 30 days of entering the study. This criterion
will be reviewed on a case by case basis by the PI/Co-I to determine appropriate
washout period. Appropriate wash out period may be greater than 30 days depending on
the half-life of the investigational drug. Participants may be eligible for study
participation after completing the washout period designated by the PI or Co-I
(physician only).
• Any MRI incompatibility as determined by most current MRI screening form
• History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder
• History of serious head trauma or seizure disorder (can be included at the discretion
of the PI or Co-I)
• Unable, in the judgement of the investigator, to comply with directions and/or
tolerate the procedures required for participation in this study
• Pregnant or breast-feeding or has a planned pregnancy during the course of the study
• Any other medical condition or disease that would impact participant safety or data
integrity in the opinion of the PI/CO-I
Other, Infections, Immune System & Allergies, Healthy Volunteers, Asthma
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations (SEACRAFT-1)
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat
sarcoma viral oncogene (RAS) Q61X solid tumors
- To evaluate the safety and tolerability of naporafenib administered with trametinib in
patients with RAS Q61X solid tumors
- To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when
administered to patients with RAS Q61X solid tumors
Dustin Deming, MD
All
12 Years to 99 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT05907304
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Key
Inclusion Criteria:
1. Willing and able to provide written informed consent
2. Age ≥ 12 years
3. A locally advanced or metastatic tumor who has progressed on or for which no standard
therapy exists. Patients who are intolerant to standard therapy or who are not a
candidate for standard therapy (in the opinion of the Investigator) or who decline
standard therapy are also eligible.
4. Documentation of a RAS Q61X mutation (tumor tissue or blood) prior to first dose of
study treatment as determined locally with an analytically validated assay in a
certified testing laboratory.
5. Archival tumor tissue collected within 5 years prior to enrollment must be confirmed
to be available at the time of Screening, which may be submitted before or after
enrollment for exploratory biomarker analysis.
6. ECOG performance status 0, 1 or 2
7. Presence of at least 1 measurable lesion according to RECIST v1.1
8. Able to swallow oral medication.
Exclusion Criteria:
1. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
2. Impairment of GI function or gastrointestinal (GI) disease that may significantly
alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
3. History or current evidence of retinal vein occlusion (RVO) or current risk factors
for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity
or hypercoagulability syndrome)
4. Corrected QT interval using Fridericia's formula (QTcF) at Screening >450 ms based on
triplicate average NOTE: criterion does not apply to patients with a right or left
bundle branch block
5. LVEF <50%
6. All primary CNS tumors
7. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled
CNS metastases are eligible.
8. Patients receiving treatment with medications that are known to be strong inhibitors
and/or inducers of cytochrome P450 (CYP)3A; substrates of CYP2C8, CYP2C9, and CYP3A
with a narrow therapeutic index and sensitive substrates of CYP3A;
9. Are pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the trial
Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Mycosis Fungoides, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Melanoma/Skin cancer, Sarcoma, Uterus, Advanced or Metastatic Solid Tumors
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)
This study will evaluate the efficacy of TNX-103 (levosimendan) compared with placebo in
subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to
Week 12).
Aurangzeb Baber
All
18 Years to 85 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT05983250
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Inclusion Criteria:
1. Men or women, greater than or equal to18 to 85 years of age.
2. NYHA Class II or III or ambulatory NYHA class IV symptoms.
3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying
hemodynamics
4. A qualifying Baseline RHC performed within 120 days. The RHC can be a historical RHC
done prior to study consent.
5. A qualifying echocardiogram performed within 30 days showing an LVEF greater than or
equal to 40%
6. A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening
7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period to establish
the resting heart rate (HR) and rhythm.
8. Chronic medications for heart failure with preserved ejection fraction (HFpEF) or
other serious underlying cardiac or pulmonary conditions should be administered at a
stable dose for greater than or equal to 30 days prior to the day of the Baseline
6-MWT.
9. Female subjects of childbearing potential must have a negative urine pregnancy test
result at the Screening Visit and a negative urine pregnancy test and must not be
pregnant, lactating, or planning a pregnancy from the Screening Visit to 7 months
after the last dose of study drug.
10. Female subjects of childbearing potential will be included if they are either sexually
inactive (abstinent) for 90 days prior to the first dose of study drug, or are using a
highly effective birth control method
11. Female subjects of nonchildbearing potential will be included if they meet the
following definition of nonchildbearing potential: are either surgically sterile or
postmenopausal.
12. Male patients with female partners of childbearing potential must use highly effective
methods of birth control during their participation in the study and for a period of 4
months after the last dose of study drug.
13. Patients must agree to abstain from egg or sperm donation through 7 months for female
patients and 4 months for male patients after administration of the last dose of study
drug.
14. Ability to adhere to study visit schedule and understand and comply with all protocol
requirements.
15. Signed informed consent document indicating that they understand the purpose and
procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
2. Walking activity that is limited by anything other than shortness of breath or fatigue
attributed to PH-HFpEF.
3. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive
cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative
cardiomyopathy
4. Structural heart repair or replacement of the aortic valve or mitral valve (surgical
or percutaneous) within the past 12 months. OR, planned valve intervention in the next
6 months. OR, the presence of echocardiographic findings of significant valve disease
as assessed from the qualifying echocardiogram
5. Any of the following clinical laboratory values within 30 days as specified:
1. Hemoglobin <10 g/dL
2. Serum alanine aminotransferase or aspartate aminotransferase levels >3× upper
limit of normal (ULN) or total bilirubin >3× ULN.
3. Electrocardiogram (ECG) with a QTcF >450 msec for males and >470 msec for females
at Screening and Baseline in the absence of right bundle branch block.
4. Platelet count <75,000/mm3.
6. A diagnosis of pre-existing lung disease
7. Recent documentation of significant underlying lung disease
8. Documentation of pulmonary thromboembolism in the last 12 months
9. Cardiovascular co-morbidities
10. Receipt of any approved pulmonary arterial hypertension-specific therapies
11. Hospitalization for any indication within 30 days
12. Receipt of any intravenous (IV) inotropes within 30 days
13. Body mass index greater than or equal to 45 kg/m2.
14. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
15. Known history of chronic liver disease
16. Prior exposure to levosimendan
17. Current enrollment in or completion of any other investigational product study within
30 days of Screening.
18. Initiation of an exercise program for cardiopulmonary rehabilitation within 45 days
19. History of severe allergic or anaphylactic reaction or hypersensitivity to the
excipients in the investigational product.
20. Major surgery within 60 days. Subjects must have completely recovered from any
previous surgery.
21. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
22. Pregnancy or breastfeeding in females
23. History of active malignancy, with the exception of fully treated basal cell
carcinoma, cervical carcinoma in situ, or squamous cell carcinomas of the skin.
24. History of clinically significant other diseases that may limit or complicate
participation in the study.
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential
activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with
mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.
Zhubin Gahvari, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05568680
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Inclusion Criteria:
• Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary
peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial
mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy
for advanced disease
• Adult 18 years of age or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• For ovarian cancer and mesothelioma, tumor expression of mesothelin ≥50% of tumor
cells with ≥2+ staining intensity (on a scale of 0 to 3). For cholangiocarcinoma ≥10%
of cells at any staining intensity (≥1+).
• Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma
or lesions measurable for mRECIST for mesothelioma.
• Satisfactory Blood coagulation parameters:
• Satisfactory organ and bone marrow function
Exclusion Criteria:
• Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian
unless surgically and medically cured without evidence of recurrent disease for 5
years.
• History of T or B cell malignancies or previous gene-engineered T cell therapies.
• Sarcomatoid/biphasic mesothelioma.
• Pulmonary exclusions:
• Have acquired hereditary, congenital immunodeficiency or have recognized
immunodeficiency disease
• Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
• Active autoimmune disease
Small Intestine, Liver, Other Digestive Organ, Lung, Other Respiratory and Intrathoracic Organs, Ovary, Other Female Genital, Gastrointestinal cancers, other, Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy
along with standard of care surgical resection of the primary tumor, radiation, stem cell
transplantation, and immunotherapy works for treating children with newly diagnosed high-risk
neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2,
which is found on the surface of neuroblastoma cells, but is not present on many healthy or
normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal
the immune system to kill the tumor cells. This helps the cells of the immune system kill the
cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given
together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical
trial randomly assigns patients to receive either standard chemotherapy and surgery or
chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy.
Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan,
cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to
stop the growth of cancer cells, either by killing the cells, by stopping them from dividing
or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a
disease evaluation is completed to determine how well the treatment worked. If the tumor
responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the
tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended
Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide.
Patients with a good response to therapy move on to Consolidation therapy, when very high
doses of chemotherapy are given at two separate points to kill any remaining cancer cells.
Following, transplant, radiation therapy is given to the site where the cancer originated
(primary site) and to any other areas that are still active at the end of Induction. The
final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given
with isotretinoin, with the goal of maintaining the response achieved with the previous
therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical
resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may
be better at treating children with newly diagnosed high-risk neuroblastoma.
Margo Hoover-Regan
All
up to 30 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT06172296
Show full eligibility criteria
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Inclusion Criteria:
• Patients must be enrolled on APEC14B1 and have consented to testing through the
Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
• ≤ 30 years at the time of initial diagnosis with high-risk disease
• Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular)
verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone
marrow with elevated urinary catecholamines
• Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:
• Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or
M and MYCN amplification
• Age ≥ 547 days and INRG stage M regardless of biologic features (clinical
MYCN testing not required prior to enrollment)
• Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have
progressed to stage M without systemic chemotherapy
• Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who
have progressed to stage M without systemic chemotherapy (clinical MYCN
testing not required prior to enrollment)
• Patients must have a BSA ≥ 0.25 m^2
• No prior anti-cancer therapy except as outlined below:
• Patients initially recognized to have high-risk disease treated with
topotecan/cyclophosphamide initiated on an emergent basis and within allowed
timing, and with consent
• Patients observed or treated with a single cycle of chemotherapy per a low or
intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or
similar) for what initially appeared to be non-high-risk disease but subsequently
found to meet the criteria
• Patients who received localized emergency radiation to sites of life threatening
or function-threatening disease prior to or immediately after establishment of
the definitive diagnosis
• Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial
• A serum creatinine based on age/sex derived from the Schwartz formula for estimating
glomerular filtration rate (GFR) utilizing child length and stature data published by
the CDC or
• a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m^2 or
• a GFR ≥ 70 mL/min/1.73 m^2. GFR must be performed using direct measurement with a
nuclear blood sampling method or direct small molecule clearance method
(iothalamate or other molecule per institutional standard) Note: Estimated GFR
(eGFR) from serum creatinine, cystatin C or other estimates are not acceptable
for determining eligibility
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
• Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase [ALT]) ≤ 10 x
ULN*
• Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L
• Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by
echocardiogram or radionuclide angiogram
• Ability to tolerate Peripheral Blood Stem Cell (PBSC) Collection:
No known contraindication to PBSC collection. Examples of contraindications might be a
weight or size less than the collecting institution finds feasible, or a physical condition
that would limit the ability of the child to undergo apheresis catheter placement (if
necessary) and/or the apheresis procedure
Exclusion Criteria:
• Patients who are 365-546 days of age with INRG Stage M and MYCN non amplified NBL,
irrespective of additional biologic features
• Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of
additional biologic features
• Patients with known bone marrow failure syndromes
• Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine,
corticosteroids) for reasons other than prevention/treatment of allergic reactions and
adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are
acceptable
• Patients with a primary immunodeficiency syndrome who require ongoing immune globulin
replacement therapy
• Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required prior to
enrollment for female patients of childbearing potential
• Lactating females who plan to breastfeed their infants
• Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation
• All patients and/or their parents or legal guardians must sign a written informed
consent
• All institutional, food and drug administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Ganglioneuroblastoma, Nodular, Neuroblastoma, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Other Hematopoietic, Unknown Sites, Ill-Defined Sites, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Melanoma/Skin cancer, Sarcoma, Uterus
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies
Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of
personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with
immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone
in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy.
Andrew Baschnagel, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05846659
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Inclusion Criteria:
1. Male or female patients ≥ 18 years of age
2. Signed informed consent and mental capability to understand the informed consent
3. Histologically or cytologically documented solid tumor malignancies demonstrating new
progression through prior anti-cancer therapy, with a prior 2 months of clinical
stability (with at least Stable Disease), with radiographically documented presence of
≤ 6 metastatic lesions consistent with the diagnosis of "oligoprogressive" disease
that are technically amenable to PULSAR
4. Patient's disease must be evaluable per RECIST Version 1.1
5. All metastatic lesions amenable to administration of radiotherapy, at the discretion
of the investigator
6. Must have at least one single pre-defined progressing lesion/lesion site (longest
diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
8. Electrocardiogram (ECG) without evidence of clinically meaningful conduction
abnormalities or active ischemia as determined by the investigator
9. Acceptable organ and marrow function as defined below:
• Absolute neutrophil count (ANC) > 1,500 cells/μL
• Platelets > 50,000 cells/μL
• Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransaminase (ALT) ≤ 2.5 × ULN. If
liver metastases are present, AST/ALT < 5 × ULN
• Serum creatinine < 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min
using the Cockcroft-Gault formula
• Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN
10. Women of child-bearing potential (defined as a female who has experienced menarche and
who has not undergone successful surgical sterilization [hysterectomy, bilateral
salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as
amenorrhea for at least 12 consecutive months with an appropriate clinical profile at
the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy
test prior to first dose of study treatment
11. Male and female patients with reproductive potential must agree to use two forms of
highly effective contraception throughout the study
Exclusion Criteria:
1. Prior receipt of stimulator of interferon genes (STING) agonist
2. Prior receipt of therapeutic radiotherapy to all progressive lesions intended for
PULSAR treatment
3. Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or < 5
half-lives of the first dose of study treatment
4. Existence of primary tumor that requires therapeutic treatment beyond the provided
immune checkpoint inhibitor drug
5. Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior
anti-cancer therapy, as judged by the investigator
6. Previous life-threatening (Grade 4) immune-related adverse event (irAE)
7. Known untreated brain metastases or treated brain metastases that have not been stable
(scan showing no worsening of central nervous system [CNS] lesion[s] and no
requirement of corticosteroids) ≥ 4 weeks prior to study enrollment
8. Existence of actionable mutations that are eligible for a mutation-targeting drug that
represents standard-of-care
9. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 470)
10. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations) that in the opinion of the
investigator would limit compliance with study requirements
11. Women who are pregnant or breastfeeding
12. Sponsor reserves the right to exclude any patient from the study on the basis of
pre-study medical histories, physical examination findings, clinical laboratory
results, prior medications, or other entrance criteria
Oligoprogressive, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Sarcoma, Uterus
Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC
Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of
personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with
immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone
in patients with NSCLC or RCC
Andrew Baschnagel, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05846646
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Male or female patients ≥ 18 years of age
2. Signed informed consent and mental capability to understand the informed consent
3. Histologically or cytologically documented NSCLC or RCC with radiographically
documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of
"oligometastatic" disease
4. Patient's disease must be evaluable per RECIST Version 1.1
5. All metastatic lesions amenable to administration of radiotherapy, at the discretion
of the investigator
6. Must have at least one single pre-defined lesion/lesion site (longest diameter ≥ 10 mm
and ≤ 50 mm) suitable for intra-tumoral injection
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
8. Electrocardiogram (ECG) without evidence of clinically significant conduction
abnormalities or active ischemia as determined by the investigator
9. Acceptable organ and marrow function as defined below:
• Absolute neutrophil count (ANC) > 1,500 cells/μL
• Platelets > 50,000 cells/μL
• Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN. If
liver metastases are present, AST/ALT < 5 × ULN
• Serum creatinine < 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min
using the Cockcroft-Gault formula
• Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN
10. Women of child-bearing potential (defined as a female who has experienced menarche and
who has not undergone successful surgical sterilization [hysterectomy, bilateral
salpingectomy, or bilateral oophorectomy]) or is not postmenopausal (defined as
amenorrhea for at least 12 consecutive months with an appropriate clinical profile at
the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy
test prior to first dose of study treatment
11. Male and female patients with reproductive potential must agree to use two forms of
highly effective contraception throughout the study
Exclusion Criteria:
1. Prior disease progression through programmed cell death ligand 1 (PD-L1 or
PD-1)-targeted immunotherapy
2. Prior receipt of stimulator of interferon genes (STING) agonist
3. Prior receipt of therapeutic radiotherapy to the lesions intended for PULSAR treatment
4. Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or < 5
half-lives of the first dose of study treatment
5. Existence of primary tumor that requires therapeutic treatment beyond the provided
immune checkpoint inhibitor drug
6. Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior
anti-cancer therapy, as judged by the investigator
7. Previous life-threatening (Grade 4) immune-related adverse event (irAE)
8. Existence of actionable mutations that may be eligible for mutation-targeted drug that
represents standard-of-care therapy
9. Presence of brain metastases
10. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval > 470)
11. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations) that in the opinion of the
investigator would limit compliance with study requirements
12. Women who are pregnant or breastfeeding
13. Sponsor reserves the right to exclude any patient from the study on the basis of
pre-study medical histories, physical examination findings, clinical laboratory
results, prior medications, or other entrance criteria
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with
Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of
Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and
key secondary endpoints include progression free survival. response and safety.
Howard Bailey, M.D.
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05899608
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Age ≥ 18 years old at the time of enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Expected life expectancy ≥ 3 months
• Metastatic (Stage IV) NSCLC
• Histologically or cytologically confirmed squamous NSCLC
• Tumor Proportion Score (TPS) with PD-L1 expression percent
• At least one measurable noncerebral lesion according to RECIST 1.1
• No prior systemic treatment for metastatic NSCLC
Exclusion Criteria:
• Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or
non-squamous NSCLC histology.
• Known actionable genomic alterations in epidermal growth factor receptor (EGFR),
anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved
therapies are available
• Has received any prior therapy for NSCLC in the metastatic setting
• Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), or major blood
vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
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