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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT04929223

Registry updated: 2026-10-09
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Description

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.

Interventions

  • Inavolisib (Drug)
    Inavolisib will be administered orally as per schedule specified in the respective arms.
  • Bevacizumab (Drug)
    Bevacizumab IV will be administered as per schedule specified in the respective arm.
  • Cetuximab (Drug)
    Cetuximab IV will be administered as per schedule specified in the respective arm.
  • Atezolizumab (Drug)
    Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
  • Tiragolumab (Drug)
    Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
  • SY-5609 (Drug)
    SY-5609 will be administered by mouth as per schedule specified in the respective arm.
  • Divarasib (Drug)
    Divarasib will be administered orally as per schedule specified in the respective arms.
  • FOLFOX (Drug)
    FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
  • FOLFIRI (Drug)
    FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
  • FoundationOne®Liquid CDx (Diagnostic test)
    FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

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

Conditions

Metastatic Colorectal Cancer

Locations

  • UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
  • Mayo Clinic Arizona — Phoenix, Arizona, United States
  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • cCare — Encinitas, California, United States
  • USC Norris Cancer Center — Los Angeles, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • UCLA — Los Angeles, California, United States
  • Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
  • Stanford Cancer Center — Stanford, California, United States
  • University of Colorado Cancer Center — Aurora, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
  • Yale Cancer Center — New Haven, Connecticut, United States
  • Eastern Ct Hema/Onco Assoc — Norwich, Connecticut, United States
  • Mayo Clinic in Florida — Jacksonville, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Illinois Cancer Specialists — Arlington Heights, Illinois, United States
  • Mary Bird Perkins Cancer Ctr — Baton Rouge, Louisiana, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • Karmanos Cancer Institute — Detroit, Michigan, United States
  • Mayo Clinic Rochester — Rochester, Minnesota, United States
  • New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York, United States
  • New York Cancer and Blood Specialists-Central Park Hematology & Oncology — New York, New York, United States
  • New York Cancer & Blood Specialists — Port Jefferson Station, New York, United States
  • New York Cancer & Blood Specialists - Bronx — The Bronx, New York, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Hematology Oncology Salem — Salem, Oregon, United States
  • UPMC - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Texas Oncology - Northeast Texas — Denton, Texas, United States
  • Lumi Research — Kingwood, Texas, United States
  • Texas Oncology - Gulf Coast — Webster, Texas, United States
  • Swedish Cancer Inst. — Seattle, Washington, United States
  • Medical Oncology Associates — Spokane, Washington, United States
  • Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
  • Princess Margaret Cancer Center — Toronto, Ontario, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • McGill University Health Center — Montreal, Quebec, Canada
  • Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed — Herlev, Denmark
  • Rigshospitalet, Onkologisk Klinik — København Ø, Denmark
  • Charité Universitätsmedizin Berlin — Berlin, Germany
  • Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital — Bochum, Germany
  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden — Dresden, Germany
  • Universitätsklinikum Düsseldorf — Düsseldorf, Germany
  • Asklepios Klinik Altona — Hamburg, Germany
  • SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III — Heilbronn, Germany
  • Klinikum der Universität München, Campus Großhadern — München, Germany
  • Universitätsklinikum Ulm — Ulm, Germany
  • Università degli Studi della Campania Luigi Vanvitelli — Naples, Campania, Italy
  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS — Meldola, Emilia-Romagna, Italy
  • Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy
  • Irccs Istituto Nazionale Dei Tumori (Int) — Milan, Lombardy, Italy
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda) — Milan, Lombardy, Italy
  • IRCCS Istituto Oncologico Veneto (IOV) — Padova, Veneto, Italy
  • Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz — Gdansk, Poland
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii — Krakow, Poland
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland
  • Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie — Warsaw, Poland
  • National Cancer Center — Goyang-si, South Korea
  • Chonnam National University Hwasun Hospital — Jeollanam-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Hospital Universitario de Donostia — Donostia / San Sebastian, Guipuzcoa, Spain
  • Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain
  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona — Barcelona, Spain
  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz — Madrid, Spain
  • START Madrid. Centro Integral Oncologico Clara Campal — Madrid, Spain
  • Hospital Clínico Universitario de Valencia — Valencia, Spain
  • Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • National Taiwan University Hospital — Zhongzheng Dist., Taiwan
  • Addenbrookes Hospital — Cambridge, United Kingdom
  • Velindre Cancer Centre — Cardiff, United Kingdom
  • Royal Free Hospital — London, United Kingdom
  • Royal Marsden Hospital;Dept of Med-Onc — London, United Kingdom
  • Sarah Cannon Research Institute — London, United Kingdom
  • Imperial College Healthcare NHS Trust — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
  • Royal Marsden Hospital — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record