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.
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
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
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
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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
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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 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
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