A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
NCT ID: NCT04929223
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
542 participants
INTERVENTIONAL
2021-10-22
2028-11-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Inavolisib + Cetuximab
Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days).
Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each. This arm is closed.
Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Inavolisib + Bevacizumab
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days). This arm is closed.
Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Atezolizumab + Tiragolumab + Bevacizumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
Atezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Tiragolumab
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Atezolizumab + Tiragolumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
Atezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Tiragolumab
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Atezolizumab + SY-5609
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) This arm is closed.
Atezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
SY-5609
SY-5609 will be administered by mouth as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Divarasib + Cetuximab + FOLFOX
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFOX
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Divarasib + Cetuximab
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Divarasib + Cetuximab + FOLFIRI
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFIRI
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Divarasib + Bevacizumab + FOLFOX
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFOX on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFOX
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Divarasib + Bevacizumab + FOLFIRI
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFIRI on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFIRI
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Interventions
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Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
Atezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Tiragolumab
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
SY-5609
SY-5609 will be administered by mouth as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFOX
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
FOLFIRI
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
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
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
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Lumi Research
Kingwood, 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
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
Napoli, Campania, 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)
Padua, Veneto, Italy
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
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
National Cheng Kung University Hospital
Tainan City, , 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
Countries
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Central Contacts
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Reference Study ID Number: WO42758 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
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2021-001207-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505163-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
WO42758
Identifier Type: -
Identifier Source: org_study_id