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

Recruiting now · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04929223

Run by

Hoffmann-La Roche

People needed

542

Starts

2021-10-22

Expected to finish

2030-08-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed cohort-specific Informed Consent Form
• Age >= 18 years at time of signing Informed Consent Form
• Biomarker eligibility as determined by:
• A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
• A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
• Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
• Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.
• 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 participants for exploratory biomarker research
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment
• 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

You may not qualify if…

• Current participation or enrollment in another interventional clinical trial. Participants 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 treatment
• 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: Participants 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 participant 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 participant compliance, or puts the patient at higher risk for treatment-related complications

Where it is running

• Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed — Herlev, Denmark (enrolling)
• Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Texas Oncology - Gulf Coast — Webster, Texas, United States (enrolling)
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Rigshospitalet, Onkologisk Klinik — København Ø, Denmark (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• Texas Oncology - Northeast Texas — Denton, Texas, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
• Mary Bird Perkins Cancer Ctr — Baton Rouge, Louisiana, United States (enrolling)
• Hematology Oncology Salem — Salem, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
• New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York, United States (enrolling)
• New York Cancer and Blood Specialists-Central Park Hematology & Oncology — New York, New York, United States (enrolling)
• New York Cancer & Blood Specialists — Port Jefferson Station, New York, United States (enrolling)
• New York Cancer & Blood Specialists - Bronx — The Bronx, New York, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital — Bochum, Germany (enrolling)

Full record on ClinicalTrials.gov

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