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Looking for participantsPhase1

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT04929223

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Inavolisib (drug), Bevacizumab (drug), Cetuximab (drug), Atezolizumab (drug)
How long the study runs
Study runs about 106 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
542
Started
2021-10-22
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic colorectal cancer
  • • Phase1 - 542 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with metastatic colorectal cancer

Where?

  • • Cambridge - Addenbrookes Hospital
  • • Cardiff - Velindre Cancer Centre
  • • London - Royal Free Hospital
  • • London - Royal Marsden Hospital;Dept of Med-Onc
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Metastatic Colorectal Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD4with a positive

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Signed cohort-specific agreement to take part Form
  • ✓Age \>= 18 years at time of signing agreement to take part Form
  • ✓test result eligibility as determined by:
  • ✓A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
See the full 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 Is This Study? (8 UK sites)

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Royal Free Hospital

London NW3 2QG, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Marsden Hospital;Dept of Med-Onc

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

Imperial College Healthcare NHS Trust

London W2 1NY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10