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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

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.

Eligibility criteria

Qualifiers

Signed cohort-specific Informed Consent Form

Age >= 18 years at time of signing Informed Consent Form

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Inavolisib
  • Bevacizumab
  • Cetuximab
  • Atezolizumab
  • Tiragolumab
  • SY-5609
  • Divarasib
  • FOLFOX
  • FOLFIRI
  • FoundationOne®Liquid CDx

Treatment groups

542 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Sponsors and collaborators