RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe targeted treatments and immune-based treatments are and how well they work, alone or together. It is for adults with colon or rectal cancer that has spread to other parts of the body. Test results showing certain cancer markers help decide which treatment group each person joins.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and sign a consent form for your study group.
  • Have adenocarcinoma, a cancer that starts in gland cells, in the colon or rectum that has spread.
  • Have cancer marker test results that qualify you for a treatment group.
  • Have had treatment for cancer that has spread, and have at least one tumor that can be measured.
  • Be fully active or able to do light work, and be expected to live at least 3 months.
  • Have blood counts and organs working well enough, checked within 14 days before treatment.
  • Be able to follow study rules and provide tumor tissue samples.
  • Agree to the required birth control or rules about not having sex. Men must also agree not to donate sperm.

Who can't join

  • Be taking part in another treatment study. People only in the follow-up part of another study may join.
  • Have had whole-body cancer treatment too recently—within 2 weeks or less, depending on the drug—or an experimental treatment within 28 days.
  • Be pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have a serious health problem, unsafe test results, lasting treatment side effects, or medicines that could make study treatment unsafe or affect the results.
  • Have had a severe infection within 4 weeks, have an active infection that could affect safety, or have not recovered enough from surgery.
  • Have uncontrolled cancer pain, high blood calcium that is uncontrolled or causes symptoms, active serious liver disease, or fluid around the lungs, heart, or belly needing drainage at least monthly.
  • Have cancer in the brain or spinal cord that causes symptoms, is untreated, or is growing; or have a history of cancer in their lining.
  • Have had another cancer within 2 years, unless it has a very low risk of spreading or causing death.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * 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 Exclusion Criteria * 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

Study sites (35)

AL

AZ

CA

CO

CT

FL

IL

LA

MA

MI

MN

NC

NY

OR

PA

TN

TX

WA