Evaluating targeted therapies for metastatic colorectal cancer
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)
Run by Hoffmann-La Roche · NCT04929223 · Data updated 2026-11-12
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 542 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 84 sites (Birmingham, Alabama and 83 other locations) |
| Status | Recruiting |
| Started | October 22, 2021 |
| Main results expected | August 31, 2030 |
| Study ends | August 31, 2030 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT04929223 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using targeted therapies for metastatic colorectal cancer, indicating that this approach is supported by prior research.
Who can join: the full rules
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 it's running
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City of Hope Comprehensive Cancer Center
Duarte, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
UCLA
Los Angeles, California, United States Recruiting -
University of Colorado Cancer Center
Aurora, Colorado, United States Recruiting -
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States Recruiting -
Yale Cancer Center
New Haven, Connecticut, United States Recruiting
Show 44 more locations
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Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
Illinois Cancer Specialists
Arlington Heights, Illinois, United States Recruiting -
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States Recruiting -
Mayo Clinic Rochester
Rochester, Minnesota, United States Recruiting -
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States Recruiting -
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, United States Recruiting -
New York Cancer & Blood Specialists
Port Jefferson Station, New York, United States Recruiting -
New York Cancer & Blood Specialists - Bronx
The Bronx, New York, United States Recruiting -
SCRI Oncology Partners
Nashville, Tennessee, United States Recruiting -
Texas Oncology - Northeast Texas
Denton, Texas, United States Recruiting -
Texas Oncology - Gulf Coast
Webster, Texas, United States Recruiting -
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia Recruiting -
Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed
Herlev, Denmark Recruiting -
Charité Universitätsmedizin Berlin
Berlin, Germany Recruiting -
Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
Bochum, Germany Recruiting -
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany Recruiting -
Universitätsklinikum Düsseldorf
Düsseldorf, Germany Recruiting -
Asklepios Klinik Altona
Hamburg, Germany Recruiting -
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
Heilbronn, Germany Recruiting -
Universitätsklinikum Ulm
Ulm, Germany Recruiting -
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy Recruiting -
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola, Emilia-Romagna, Italy Recruiting -
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy Recruiting -
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy Recruiting -
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, Italy Recruiting -
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gdansk, Poland Recruiting -
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland Recruiting -
National Cancer Center
Goyang-si, South Korea Recruiting -
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea Recruiting -
Seoul National University Bundang Hospital
Seongnam-si, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
Seoul National University Hospital
Seoul, South Korea Recruiting -
Severance Hospital, Yonsei University Health System
Seoul, South Korea Recruiting -
Asan Medical Center
Seoul, South Korea Recruiting -
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, Spain Recruiting -
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain Recruiting -
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain Recruiting -
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain Recruiting -
Hospital Clínico Universitario de Valencia
Valencia, Spain Recruiting -
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain Recruiting -
National Cheng Kung University Hospital
Tainan, Taiwan Recruiting -
Taipei Veterans General Hospital
Taipei, Taiwan Recruiting -
National Taiwan University Hospital
Zhongzheng Dist., Taiwan Recruiting -
Addenbrookes Hospital
Cambridge, United Kingdom Recruiting
+34 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.