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Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical
trials to study cancer treatment directed by genetic testing. Patients with solid tumors that
have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places
in the body (advanced) and have progressed on at least one line of standard systemic therapy
or have no standard treatment that has been shown to prolong overall survival may be
candidates for these trials. Genetic tests look at the unique genetic material (genes) of
patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may
benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed
to match patients to a treatment that may work to control their tumor and may help doctors
plan better treatment for patients with locally advanced or advanced solid tumors.
Nataliya Uboha, MD
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT05564377
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Inclusion Criteria:
• Patient must have measurable disease
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
between 0-2 OR patient must have Lansky performance status of >= 50% or Karnofsky
performance status of >= 50%
• Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as
assessed by the enrolling provider
• All patients must have sequencing results available from a National Cancer Institute
(NCI) credentialed Designated Laboratory (DL)
• Patients must have locally advanced or advanced histologically documented solid tumors
requiring therapy and meet one of the following criteria:
• Patients must have progressed on at least one line of standard systemic therapy
OR
• Patients whose disease has no standard treatment that has been shown to prolong
overall survival
• Patient must meet one of the following requirements:
• Patients 18 years and older who have tumor amenable to minimal risk image-guided
or direct vision biopsy and must be willing and able to undergo a tumor biopsy to
obtain samples for research if the patient is to enroll in a ComboMATCH treatment
trial OR
• Patients 18 years and older who do not have disease that is biopsiable at minimal
risk to the patient must confirm availability of an archival tumor tissue
specimen for submission for research if the patient enrolls to a ComboMATCH
Treatment Trial. This tumor tissue must meet the following criteria:
• Tissue must have been collected within 12 months prior to registration to
the EAY191 Registration Trial
• Patient must not have had a Response Evaluation Criteria in Solid Tumors
(RECIST) response (complete response [CR] or partial response [PR]) to any
intervening therapy after collection of the tissue
• Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available OR
• Patients under 18 years old must confirm availability of an archival tumor tissue
specimen for submission for research if patient enrolls to a ComboMATCH Treatment
Trial. This tumor tissue must meet the following criteria:
• Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be
available
• NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and
management instructions. Performance of the mandatory research biopsy or
submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection
and submission of the blood specimens for the integrated studies will be
performed under the consent authority of the specific treatment trial protocol to
which the patient is registered. No procedures to collect specimens for research
only are to be performed for patients registered to the EAY191 Registration Trial
only
• NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If
patient is found to not be eligible for the assigned ComboMATCH Treatment Trial,
indication of ineligibility will trigger re-evaluation and potential assignment to
another Treatment 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, 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, 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, Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial
This phase II ComboMATCH treatment trial tests the usual treatment of chemotherapy
(paclitaxel) plus ipatasertib in patients with solid tumor cancers that that cannot be
removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally
advanced) or from where it first started (primary site) to other places in the body
(metastatic), and has an AKT genetic change. Chemotherapy drugs, such as paclitaxel, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Targeted therapy, such as
Ipatasertib, may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. The addition of ipatasertib to paclitaxel in solid tumors with an AKT genetic
change could increase the percentage of tumors that shrink as well as lengthen the time that
the tumors remain stable (without progression). Researchers hope to learn if paclitaxel plus
ipatasertib will shrink this type of cancer or stop its growth.
Nataliya Uboha, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05554380
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Inclusion Criteria:
• Patient must have enrolled onto EAY191 and must have been given a treatment assignment
to ComboMATCH to EAY191-S3 based on the presence of an actionable mutation as defined
in EAY191
• GENERAL COMBOMATCH EAY191 REGISTRATION INCLUSION CRITERIA:
• Participants must be enrolled on the ComboMATCH Master Registration Trial EAY191
• Participants must have an activating AKT mutation (a known mutation in AKT1, AKT2, or
AKT3, a single nucleotide variant, insertion, or deletion) as determined by the
ComboMATCH screening assessment
• GENERAL COMBOMATCH EAY191 REGISTRATION EXCLUSION CRITERIA:
• Participants must not have an activating KRAS, NRAS, HRAS, or BRAF mutation (a single
nucleotide variant, insertion, or deletion) as determined by the ComboMATCH screening
assessment
• Participants must have disease that can be safely biopsied and agree to a
pre-treatment biopsy or have archival tissue available from within 12 months prior to
the date of registration on the ComboMATCH Registration Trial (EAY191)
• Participants must have a histologically confirmed non-breast solid malignancy
• Participants must have locally advanced, unresectable, or metastatic disease in the
opinion of the treating investigator
• Participants must have measurable disease documented by CT or MRI. Measurable disease
must be assessed within 28 days prior to registration. Non-measurable disease must be
assessed within 42 days prior to registration. The CT from a combined positron
emission tomography (PET)/CT may be used only if it is of diagnostic quality. All
known sites of disease must be assessed and documented on the Baseline Tumor
Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
Participants whose only measurable disease is within a previous radiation therapy port
must demonstrate clearly progressive disease (in the opinion of the treating
investigator) prior to registration
• Participants with known brain metastases must have a CT/MRI scan to evaluate for
central nervous system (CNS) disease and show no evidence of progression within 42
days prior to registration
• Participants must have completed any CNS-directed therapy and/or local therapy for
spinal cord compression at least 28 days prior to registration
• Participants must not have spinal cord compression or brain metastases unless: (1)
metastases have been locally treated and have remained clinically controlled and
asymptomatic for at least 14 days prior to registration, AND (2) participant has no
residual neurological dysfunction and has been off corticosteroids for at least 24
hours prior to registration
• Participants must not have leptomeningeal disease
• Participants must have progressed within 6 months of taxane-based therapy in the
neoadjuvant/adjuvant or metastatic setting
• Participants must not have received any prior AKT inhibitor (e.g., capivasertib or
ipatasertib); prior PI3K/mTOR inhibitor is acceptable
• Participants must not be planning to receive any concurrent chemotherapy,
immunotherapy, biologic, radiation, or hormonal therapy for cancer treatment while
receiving treatment on this study
• Participants must be >= 18 years of age
• Participants must be able to swallow oral medications whole
• Participants must have a pre-study history and physical exam done within 28 days prior
to registration
• Participants must have a Zubrod performance status of 0-2 within 28 days prior to
registration
• Participants must have adverse events resolved =< grade 1 related to any prior
therapy, except alopecia within 14 days prior to registration
• Participants with neuropathy must have resolved to < grade 2 within 14 days prior to
registration
• Leukocytes >= 3 x 10^3/uL (within 28 days prior to registration)
• Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to registration)
• Platelets >= 100 x 10^3/uL (within 28 days prior to registration)
• Total bilirubin =< institutional upper limit of normal (ULN) unless history of
Gilbert's disease. Participants with history of Gilbert's disease must have total
bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
• Aspartate aminotransferase (AST) & alanine aminotransferase (ALT) =< 3 x institutional
ULN (within 28 days prior to registration)
• Participants must have adequate cardiac function, class IIB (2B) or better.
Participants with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification
• Participants must have a measured OR calculated creatinine clearance >= 50 mL/min
using the following Cockcroft-Gault formula. This specimen must have been drawn within
28 days prior to registration
• Participants with known human immunodeficiency virus (HIV)-infection must be receiving
anti-retroviral therapy and have an undetectable viral load test on the most recent
test results obtained within 6 months prior to registration
• Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load on suppressive therapy within 28 days prior to
registration
• Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. Participants with HCV infection who are currently on treatment must
have an undetectable HCV viral load within 28 days prior to registration
• Participants must have an electrocardiography (ECG) performed (if clinically indicated
with a corrected QTc interval of =< 470 msec) within 28 days prior to registration
• Participants must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to ipatasertib and/or paclitaxel
• Participants must not have an active small/large bowel inflammation such as ulcerative
colitis or Crohn's disease
• Participants must not have grade 2 or higher uncontrolled intercurrent illness
• NOTE: To receive an agent, participant must not have any uncontrolled
intercurrent illness requiring antibiotic/antiviral/antifungal therapy or
interventional procedures. Participants with infections unlikely to be resolved
within 2 weeks following registration should not be considered for the trial
• Participants must not have a known grade 2 or higher uncontrolled or untreated
hypercholesterolemia or hypertriglyceridemia
• Participants must not have any of the following:
• Cirrhosis at a level of Child-Pugh B (or worse),
• Cirrhosis (any degree) and a history of hepatic encephalopathy, or
• Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful
ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
• Participants must not be receiving any medications or substances that are inhibitors
or inducers of CYP3A. Treatment with strong CYP3A inhibitors or strong CYP3A inducers
within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to
initiation of study drug is prohibited.
• NOTE: Because the lists of these agents are constantly changing, it is important
to regularly consult a frequently updated medical reference. As part of the
enrollment/informed consent procedures, the participant will be counseled on the
risk of interactions with other agents, and what to do if new medications need to
be prescribed or if the participant is considering a new over-the-counter
medicine or herbal product. The participant wallet card should be presented to
the participant
• Participants must not have baseline fasting glucose (after 8-hour fast) > 160 mg/dL
(8.9 mmol/L) within 28 days prior to registration
• Participants with known diabetes mellitus must not require insulin therapy or have a
baseline fasting glucose >150 mg/dL (8.3 mmol/L) or high glycosylated hemoglobin
(Hb)A1c, (>= 8.0%), suggesting poorly controlled diabetes
• Participants who are on a stable dose of oral diabetes medication >= 2 weeks prior to
initiation of study drug treatment are eligible for enrollment
• Participants with a prior or concurrent malignancy whose natural history or treatment
(in the opinion of the treating physician) must not have a potential to interfere with
the safety or efficacy assessment of the investigational regimen
• Participants must not have lung disease requiring active systemic therapy or placing
participants at increased risk of toxicity related to study-directed therapy
including, but not limited to pneumonitis, interstitial lung disease, idiopathic
pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of
opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia)
• Participants must not be pregnant or nursing. Individuals who are of reproductive
potential must have agreed to use an effective contraceptive method with details
provided as a part of the consent process. A person who has had menses at any time in
the preceding 12 consecutive months or who has semen likely to contain sperm is of
"reproductive potential". In addition to routine contraceptive methods, "effective
contraception" also includes surgery intended to prevent pregnancy (or with a
side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy,
bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the
semen
• Participants must not have psychiatric illness/social situations that would limit
compliance with study requirements
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, 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, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
Study of DF9001 in Patients With Advanced Solid Tumors
DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell
activation signals to specific receptors on cancer cells. The study will occur in two phases.
The first phase will be a dose escalation phase, enrolling patients with various types of
solid tumors that express epidermal growth factor receptor (EGFR). The second phase will
include a dose expansion using the best dose selected from the first phase of the study.
Multiple cohorts will be opened with eligible patients having selected solid tumors
(monotherapy and in combination with pembrolizumab).
Nataliya Uboha, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05597839
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Inclusion Criteria:
General (applies to all cohorts)
1. Signed written informed consent.
2. Male or female patients aged ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry
and an estimated life expectancy of at least 3 months.
4. Adequate hematological function per protocol.
5. Adequate hepatic function per protocol.
6. Adequate renal function per protocol.
7. Participation in the use of contraception during the study, and for 150 days after the
last dose of study drug for women of child-bearing potential (WOCBP) and 30 days after
the last dose of study drug for male patients, as defined by the Clinical Trial
Facilitation Group (CTFG) guidelines.
Inclusion Criteria:
Dose Escalation (Monotherapy)
1. Histologically proven locally advanced or metastatic solid tumors of epithelial origin
that (1) have squamous NSCLC or HNSCC, (2) has documented EGFR protein expression or
EGFR amplification or polysomy in their medical history from previous testing, or (3)
test positive for EGFR expression via archival or fresh biopsy tissue prior to study
enrollment using a validated immunohistochemistry (IHC) assay.
2. Evidence of objective disease, but participation does not require a measurable lesion.
Inclusion Criteria:
Head and Neck Squamous Cell Carcinoma (HNSCC) Expansion Cohorts
1. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST
1.1.
2. Histologically documented relapsed or metastatic HNSCC. Primary tumor locations
include oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a
primary tumor site of nasopharynx (any histology).
3. Patients must have radiographic disease progression while on or after having received
both platinum-based or fluoropyrimidine-based chemotherapy and an anti-PD-(L)1
therapy, administered either concurrent or sequentially.
4. Willing and able to provide the most recently available tissue blocks representing
tumor biopsy obtained prior to treatment initiation. If recent tissue is not
available, then a newly obtained baseline biopsy of an accessible tumor is required.
Note that "recent" is defined as no intervening systemic anticancer therapies from the
time of the last treatment of the prior therapy until screening for this trial.
5. Willing to undergo on-treatment biopsies, if safe and medically feasible.
Inclusion Criteria:
Renal Cell Carcinoma (RCC) Expansion Cohorts
1. Patients must have radiographic progression during treatment or after completing
treatment for advanced (recurrent/unresectable/metastatic) disease or be intolerant to
prior therapy.
2. Histologically documented relapsed or metastatic RCC that has documented EGFR
expression or EGFR gene amplification or polysomy in their medical history from
previous testing or test positive for EGFR expression (Section 6.2 EGFR Positivity)
via archival (only if a block is available) or fresh biopsy tissue prior to study
enrollment using a validated IHC assay. Cytology specimens cannot be used for the
purpose of defining EGFR expression to meet eligibility.
3. Patients with clear cell RCC (ccRCC) must have radiographic progression after receipt
of one of the following combination regimens as the preceding line of therapy:
1. PD-1/PD-L1-targeting mAb with or without a VEGFR-TKI.
2. PD-1-targeting mAb with a CTLA-4 monoclonal.
3. Patients with non-clear cell RCC (nccRCC) are not required to have received prior
therapy in the metastatic setting.
4. Patients with RCC in general are not required to have received TKI therapy (eg,
axitinib, cabozantinib, lenvatinib + everolimus, tivozanib).
4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST
1.1.
5. Willing and able to provide the most recently available tissue blocks representing
tumor biopsy obtained prior to treatment initiation. If recent tissue is not
available, then a newly obtained baseline biopsy of an accessible tumor is required.
Note that "recent" is defined as no intervening systemic anticancer therapies from the
time of the last treatment of the prior therapy until screening for this trial.
6. Willing to undergo on-treatment biopsies, if safe and medically feasible.
Inclusion Criteria:
Non-Small Cell Lung Cancer (NSCLC) Expansion Cohorts
1. Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IIIC, or
stage IV NSCLC disease with or without actionable genomic alterations (AGA) (per the
7th IASLC classification of NSCLC), or recurrent disease.
1. Patients with squamous NSCLC do not require EGFR testing as part of this study to
be eligible.
2. Non-squamous NSCLC patients who have documented EGFR expression or EGFR gene
amplification or polysomy in their medical history from previous testing or test
positive for EGFR expression (Section 6.2 EGFR Positivity) via archival (only if
a block is available) or fresh biopsy tissue prior to study enrollment using a
validated IHC assay.
3. Patients with stage IIIB or IIIC must be ineligible for local therapies with
curative intent (eg, radiotherapy or surgery).
2. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST
1.1.
3. Patients must have recurrent or progressive disease during or after first line
combination therapy with checkpoint inhibitors and platinum-based chemotherapy OR must
have recurrent or progressive disease within 6 months after completing platinum- based
chemotherapy for local disease, including those with actionable genetic alterations.
They must not have received any subsequent lines of therapy.
4. Status for actionable mutations (EGFR, ALK, ROS1, RET, etc.) must be known (when
testing is available as per country/region standard of care practices); patients with
actionable mutations must have received and progressed on, have been intolerant to, or
not be a candidate for standard TKIs (as available per country/region standard of care
practices).
5. Willing and able to provide the most recently available tissue blocks representing
tumor biopsy obtained prior to treatment initiation. If recent tissue is not
available, then a newly obtained baseline biopsy of an accessible tumor is required.
Note that "recent" is defined as no intervening systemic anticancer therapies from the
time of the last treatment of the prior therapy until screening for this trial.
6. Willing to undergo on-treatment biopsies, if safe and medically feasible.
Exclusion Criteria:
1. Patients must not have had chemotherapy, radiotherapy (other than palliative bone-
directed radiotherapy, as described in in exclusion criterion #2), or major surgery,
or received another investigational agent within 28 days or 5 half-lives of the drug
(if known), whichever is shorter, before the start of study treatment.
2. Received prior radiotherapy within 2 weeks of start of study intervention, or has
radiation-related toxicities, requiring corticosteroids.
a. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system
(CNS) disease is permitted. The last radiotherapy treatment must have been performed
at least 7 days before the first dose of study intervention.
3. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study intervention.
4. Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for
palliative bone-directed radiotherapy, which is not a target lesion], immune therapy,
or cytokine therapy [except for erythropoietin]), major surgery (excluding prior
diagnostic biopsy), concurrent systemic therapy with steroids or other
immunosuppressive agents, or use of any investigational drug within 28 days or 5
half-lives of the drug (if known), whichever is shorter, before the start of study
treatment. Short-term administration of systemic steroids (eg, for allergic reactions
or the management of irAEs) is allowed. Note: Patients receiving bisphosphonate or
denosumab are eligible, provided treatment was initiated at least 14 days before the
first dose of DF9001.
5. Previous malignant disease other than the target malignancy to be investigated in this
study within the last 3 years. Exceptions (eg, basal or squamous cell carcinoma of the
skin, or cervical carcinoma in situ) can be considered on a case-by-case basis, in
consultation with the Medical Monitor.
6. Life expectancy of less than 6 months.
7. Receipt of any organ transplantation, including autologous or allogeneic stem-cell
transplantation.
8. Significant acute or chronic infections (including historic positive test for human
immunodeficiency virus [HIV], or active or latent hepatitis B or active hepatitis C
tested during the screening window). If HBsAg is negative and the anti-hepatitis B
core antibody is positive, then hepatitis B viral DNA load must be undetectable.
9. Preexisting autoimmune disease (except for patients with vitiligo) needing treatment
with systemic immunosuppressive agents for more than 28 days within the last 3 years,
or clinically relevant immunodeficiencies (eg, dysgammaglobulinemia or congenital
immunodeficiencies). Patients with a history of immune-related endocrinopathies (eg,
hypothyroidism, type 1 diabetes mellitus [TIDM], and adrenal insufficiency) that are
stable on hormone replacement therapy may be eligible for this study.
10. Patients with a known medical history that may place them at risk of known toxicities
of EGFR blockade.
1. History of or ongoing keratitis, ulcerative keratitis, or corneal perforation.
2. History of cardiopulmonary arrest unless this was caused by an acute, reversible
etiology that is no longer present.
3. History of or ongoing pulmonary fibrosis or interstitial lung disease.
11. Known severe hypersensitivity reactions to mAbs (≥ Grade 3 of the NCI-CTCAE v5.0), any
history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly
controlled asthma).
12. Persisting toxicity related to prior therapy >Grade 1 NCI-CTCAE v5.0; however,
alopecia ≤Grade 2, endocrinopathies ≤Grade 2, and sensory neuropathy ≤ Grade 2 is
acceptable.
13. Patients who have received an anti-PD-(L)1 as a previous line of therapy that have
experienced either of the following:
1. a Grade 3 or Grade 4 drug-related toxicity.
2. a Grade 2 drug-related toxicity that impacted either the lungs, cardiac, or the
nervous system, caused by the administration of the anti-PD-(L)1.
14. Received any prior immunotherapy and was discontinued from that treatment due to a
Grade 3 or higher irAE (except endocrine disorders that can be treated with
replacement therapy) or was discontinued from that treatment due to Grade 2
myocarditis or recurrent Grade 2 pneumonitis.
15. A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment.
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required.
16. Has received a live or live-attenuated vaccine within 30 days prior to the first dose
of study intervention. Administration of killed vaccines are allowed.
17. Pregnancy or lactation in females during the study.
18. Known alcohol or drug abuse.
19. Serious cardiac illness or medical conditions, including but not limited to:
1. History of New York Heart Association class III or IV heart failure or systolic
dysfunction (left ventricular ejection fraction [LVEF] <55%).
2. High-risk uncontrolled arrhythmias (eg, tachycardia with a heart rate >100/min at
rest).
3. Significant ventricular arrhythmia (ventricular tachycardia) or higher-grade
atrioventricular (AV) block (eg, AV-block, second degree AV block Type 2 [Mobitz
2], or third-degree AV-block).
4. Angina pectoris requiring anti-anginal medication.
5. Clinically significant valvular heart disease.
6. Evidence of transmural infarction on electrocardiograms (ECGs).
7. Poorly controlled hypertension (defined as systolic >160 mm Hg or diastolic >100
mm Hg).
8. Clinically relevant uncontrolled cardiac risk factors, clinically relevant
pulmonary disease, or any clinically relevant medical condition in the opinion of
the Investigator that may limit participation in this study.
9. Severe dyspnea at rest due to complications of advanced malignancy or requiring
supplementary oxygen therapy.
20. All other significant diseases (eg, inflammatory bowel disease), which, in the opinion
of the Investigator, might impair the patient's ability to participate.
21. Any psychiatric condition that would prohibit the understanding or rendering of
informed consent.
22. Legal incapacity or limited legal capacity.
23. Incapable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICF and in this protocol.
24. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first
dose of study treatment (for NSCLC cohorts only).
25. Patients with brain metastases, unless all of the following criteria are met:
1. CNS lesions are asymptomatic, previously treated and no active therapy is
required (ie, no corticosteroids for edema),
2. Radiologically stable (ie, without evidence of progression) for at least 4 weeks
as confirmed by repeat imaging performed during the study screening, are
clinically stable and have not required steroid treatment for at least 14 days
before the first dose of study intervention.
3. Imaging demonstrates stability of disease 28 days from last treatment for CNS
metastases.
26. Active autoimmune disease that has required systemic treatment in past 2 years except
replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).
27. Patients with leptomeningeal disease are excluded.
28. History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
29. Active infection requiring systemic therapy.
30. Severe hypersensitivity (≥Grade 3) to pembrolizumab, and/or any of its excipients.
Solid Tumor, Adult, 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
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study (SAMURAI)
This phase II trial tests whether the addition of radiation to the primary tumor, typically
given with stereotactic ablative radiation therapy (SABR), in combination with standard of
care immunotherapy improves outcomes in patients with renal cell cancer that is not
recommended for surgery and has spread to other places in the body (metastatic). Radiation
therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body
radiation therapy uses special equipment to position a patient and deliver radiation to
tumors with high precision. This method may kill tumor cells with fewer doses of radiation
over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal
antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's
immune system attack the cancer, and may interfere with the ability of tumor cells to grow
and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called
antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen
and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in
combination with standard of care immunotherapy may help shrink or stabilize the cancer in
patients with renal cell cancer.
Hamid Emamekhoo, M.D.
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05327686
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Inclusion Criteria:
• Pathologically (histologically or cytologically) proven diagnosis of renal cell
carcinoma prior to registration
• Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following
diagnostic workup:
• History/physical examination within 45 days prior to registration
• CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days
prior to registration
• Patients must have IMDC intermediate (1-2 factors) or poor risk disease (>= 3 factors)
• 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 are eligible for this trial
• Patients with measurable disease (node positive or metastatic) as defined by RECIST
version 1.1 excluding the primary renal tumor
• Patient not recommended for or refused immediate cytoreductive nephrectomy
• Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF
combination regimen
• Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on
axial imaging
• Age >= 18
• Karnofsky performance status >= 60 within 45 days prior to registration
• Hemoglobin >= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)
• Platelet count >= 50,000/mm^3 (within 45 days prior to registration)
• Absolute neutrophil count (ANC) >= 1500/mm^3 (within 45 days prior to registration)
• Calculated (Calc.) creatinine clearance >= 30 mL/min (within 45 days prior to
registration)
• For African American patients specifically whose renal function is not considered
adequate by the formula above, an alternative formula that takes race into
account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula)
should be used for calculating the related estimated glomerular filtration rate
(GFR) with a correction factor for African American race creatinine clearance for
trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert
Syndrome, who can have total bilirubin < 3.0 mg/dL) (within 45 days prior to
registration)
• Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 3 x upper
limit of normal (ULN) or < 5 x ULN if hepatic metastases present (within 45 days prior
to registration)
• Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial.
Testing is not required for entry into protocol
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. Patients with HCV infection who are currently on treatment are eligible if
they have an undetectable HCV viral load
• The patient must agree to use a highly effective contraception, including men with
vasectomies if they are having sex with a woman of childbearing potential or with a
woman who is pregnant, while on study drug and for 6 months following the last dose of
study drug. Childbearing potential is defined as any person who has experienced
menarche and who has not undergone surgical sterilization (hysterectomy or bilateral
oophorectomy) or who is not postmenopausal
• 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:
• Patients with planned treatment of all metastatic disease with definitive therapy
including either surgery, ablative (non-palliative) doses of radiation, or
intervention of some type (definitive interventional radiology techniques) to ALL
metastatic sites rendering the patient without extra-renal measurable disease.
Patients NOT planned for definitive treatment of all metastatic sites are eligible.
Lesions radiated palliatively are not eligible for response assessment
• Patients with untreated or unstable brain metastases or cranial epidural disease
• Note: Patients who have been adequately treated with radiotherapy, radiosurgery,
or surgery and stable for at least 4 weeks prior to registration as documented by
MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated
brain metastases are defined as having no ongoing requirement for steroids and no
evidence of progression or hemorrhage after treatment for at least 4 weeks prior
to registration as documented by MRI or CT imaging or deemed stable by clinical
investigator
• Prior radiotherapy to the kidney that would result in overlap of radiation therapy
fields treatment of the primary tumor
• Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90
days before registration, note that prior chemotherapy for a different cancer is
allowed (completed > 3 years prior to registration)
• Severe, active comorbidity defined as follows:
• Active autoimmune disease requiring ongoing therapy including systemic treatment
with corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications daily. Inhaled steroids and adrenal replacement
steroid doses > 10 mg daily prednisone equivalents are permitted in the absence
of active autoimmune disease
• History of severe allergic, anaphylactic or other hypersensitivity reactions to
chimeric or humanized antibodies
• Active tuberculosis (purified protein derivative [PPD] response without active
tuberculosis [TB] is allowed)
• Uncontrolled hypertension (systolic blood pressure [BP] > 190 mmHg or diastolic
BP > 110 mmHg)
• Major surgery requiring hospital admission ≤ 28 days prior to registration.
• Any serious (requiring hospital stay or long-term rehab) non-healing wound,
ulcer, or bone fracture within 45 days prior to registration
• Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-ST
elevation myocardial infarction [NSTEMI], cerebrovascular accident [CVA], etc)
events within 180 days prior to registration
• Active New York (NY) Heart Association class 3-4 heart failure symptoms
• Moderate or severe hepatic impairment (Child-Pugh B or C)
• Any history of untreated pulmonary embolism or deep venous thrombosis (DVT)
within 180 days prior to registration. (Any asymptomatic or treated pulmonary
embolism or asymptomatic treated deep venous thrombosis > 30 days prior to
registration is allowed)
• Unstable cardiac arrhythmia within 180 days prior to registration
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal
abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior
to registration
• History of or active inflammatory bowel disease
• Malabsorption syndrome within 45 days prior to registration
• Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing
potential must have a negative pregnancy test =< 45 days prior to registration
Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Unresectable Renal Cell Carcinoma, Kidney
Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
The study's objective is to evaluate the additive value of renal biomarkers (from blood and
urine) for identifying individuals at high risk for severe acute kidney injury (AKI) above
that of a novel natural language processing (NLP)-based AKI risk algorithm. The risk
algorithm is based on electronic health records (EHR) data (labs, vitals, clinical notes, and
test reports). Patients will enroll at the University of Chicago Medical Center and the
University of Wisconsin Hospital, where the risk score will run in real time. The risk score
will identify those patients with the highest risk for the future development of Stage 2 AKI
and collect blood and urine for biomarker measurement over the subsequent 3 days.
Matthew Churpek
All
18 Years and over
IV
This study is NOT accepting healthy volunteers
NCT05988658
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Inclusion Criteria:
1. Age ≥ 18 years
2. E-STOP AKI 2.0 score in the top 10% of risk (historically from all hospitalized
patients) within the last 12 hours. (First time across this 10% risk threshold during
this hospital stay).
3. Admitted to an inpatient ward, intermediate, or ICU care at the University of Chicago
Medical Center (UCMC) or University of Wisconsin Health (UWHealth). (No Emergency
Department patients)
4. Patient or their legally authorized representative must be able to read, speak, and
understand English, for the purposes of consenting. Otherwise, inclusion in this
protocol will be done without regard to race, ethnic origin or gender
Exclusion Criteria:
1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal
transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine >4.0 mg/dl at the time of admission or available in the EHR
from the last 6 months
5. Patients with prior episode of KDIGO defined AKI during this same hospitalization-
regardless of E-STOP AKI 2.0 score
6. Patients with prior renal consultation during their admission.
7. Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago
during this same hospital stay.
8. Incarcerated patients
9. Pregnant patients
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
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
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, Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
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 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
Show full eligibility criteria
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Inclusion Criteria:
1. Male or female participants ≥18 years of age
2. Dose Escalation Phase (Part 1):
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):
1. Cohort 1: Patients with Pancreatic Ductal Adenocarcinoma (PDAC).
• Pathologically confirmed PDAC with a documented mutation in KRAS.
• Received only 1 prior line of systemic therapy in the advanced or metastatic
setting.
2. Cohort 2: Patients with Non-Small Cell Lung Cancer (NSCLC)
• Pathologically confirmed NSCLC with a documented mutation in KRAS, NRAS,
NF1, or BRAF.
• Received at least 2 prior lines but no more than 4 prior lines of systemic
therapy in the advanced or metastatic setting.
3. Cohort 3: Patients with Colorectal Cancer (CRC)
• Pathologically confirmed CRC with a documented mutation in KRAS, NRAS, NF1,
or BRAF.
• Received at least 2 prior lines of systemic therapy in the advanced or
metastatic setting.
4. Cohort 4: Patients with Melanoma
• Pathologically confirmed melanoma with a documented mutation in NRAS.
• Received at least 1 but not more than 2 prior lines of systemic therapy in
the advanced or metastatic setting that included T-cell checkpoint
inhibitor-based therapy.
• Have not received prior MEK inhibitor therapy.
5. 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 an 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 (eg, 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
8. Systemic venous thrombotic events
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
Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Melanoma, Advanced Solid Tumor, Metastatic 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, 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
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