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Evaluating targeted therapies for metastatic colorectal cancer

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)

Phase 1 Interventional Hoffmann-La Roche · NCT04929223

This study is testing if targeted therapies and immunotherapy can help people with metastatic colorectal cancer who have certain biomarkers in their tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment542 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsimmunotherapy
Locations76 sites (Birmingham, Alabama and 75 other locations)
Trial IDNCT04929223 on ClinicalTrials.gov

What this trial studies

This open-label, exploratory study aims to assess the safety and efficacy of targeted therapies and immunotherapy in patients with metastatic colorectal cancer (mCRC) who have specific biomarker-positive tumors. Participants will be assigned to treatment arms based on their biomarker assay results, allowing for a tailored approach to therapy. The interventions include various agents such as Inavolisib, Bevacizumab, Cetuximab, Atezolizumab, and Tiragolumab. The study seeks to provide insights into how these therapies can be effectively utilized in specific patient subpopulations.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with metastatic colorectal cancer who have tumors that are biomarker positive according to specific assay results.

Not a fit: Patients without the specified biomarker positivity or those who are not eligible based on the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with metastatic colorectal cancer.

How similar studies have performed: Other studies have shown promise in using targeted therapies for metastatic colorectal cancer, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerKRAS G12C
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.