A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)


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Trial ID: NCT04929223


This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Official Title

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Stanford Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.

Colleen Haas Chair in the School of Medicine


Inclusion Criteria

   - Signed cohort-specific Informed Consent Form

   - Age >= 18 years at time of signing Informed Consent Form

   - Biomarker eligibility as determined at a College of American Pathologists/clinical
   laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited
   diagnostic laboratory using a validated test

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1

   - Life expectancy >= 3 months, as determined by the investigator

   - Histologically confirmed adenocarcinoma originating from the colon or rectum

   - Metastatic disease

   - Prior therapies for metastatic disease

   - Ability to comply with the study protocol, in the investigators judgment

   - Measurable disease (at least one target lesion) according to Response Evaluation
   Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

   - Baseline tumor tissue samples will be collected from all patients for exploratory
   biomarker research

   - Adequate hematologic and organ function within 14 days prior to initiation of study

   - For women of childbearing potential: agreement to remain abstinent (refrain from
   heterosexual intercourse) or use contraceptive measures

   - For men: agreement to remain abstinent or use contraceptive measures, and agreement to
   refrain from donating sperm

Exclusion Criteria

   - Current participation or enrollment in another interventional clinical trial. Patients
   who are participating in the follow-up period of an interventional clinical trial are
   eligible for the study.

   - Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is
   shorter) prior to start of study treatment

   - Treatment with investigational therapy within 28 days prior to initiation of study

   - Pregnant or breastfeeding, or intending to become pregnant during the study

   - History of or concurrent serious medical condition or abnormality in clinical
   laboratory tests that, in the investigator's judgment, precludes the patient's safe
   participation in and completion of the study or confounds the ability to interpret
   data from the study

   - Severe infection within 4 weeks prior to initiation of study treatment or any active
   infection that, in the opinion of the investigator, could impact patient safety

   - Incomplete recovery from any surgery prior to the start of study treatment that would
   interfere with the determination of safety or efficacy of study treatment

   - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
   drainage procedures (once monthly or more frequently)

   - Uncontrolled tumor-related pain

   - Uncontrolled or symptomatic hypercalcemia

   - Clinically significant and active liver disease

   - Negative HIV test at screening, with the following exception: Patients with a positive
   HIV test at screening are eligible provided they are stable on anti-retroviral therapy
   for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an
   undetectable viral load, and have not had a history of opportunistic infection
   attributable to AIDS within the last 12 months.

   - Symptomatic, untreated, or actively progressing CNS metastases

   - History of leptomeningeal disease or carcinomatous meningitis

   - History of malignancy other than CRC within 2 years prior to screening, with the
   exception of malignancies with a negligible risk of metastasis or death

   - Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction,
   physical examination finding, or clinical laboratory finding that contraindicates the
   use of an investigational drug, may affect the interpretation of the results, or may
   render the patient at high risk from treatment complications

   - Requirement for treatment with any medicinal product that contraindicates the use of
   any of the study treatments, may interfere with the planned treatment, affects patient
   compliance, or puts the patient at higher risk for treatment-related complications


drug: Inavolisib

drug: Bevacizumab

drug: Cetuximab

drug: Atezolizumab

drug: Tiragolumab

drug: SY-5609

drug: Divarasib

drug: FOLFOX



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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alyson Beebe

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