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

NCT04929223 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Inavolisib

Inavolisib will be administered orally as per schedule specified in the respective arms.

DRUG

Bevacizumab

Bevacizumab IV will be administered as per schedule specified in the respective arm.

DRUG

Cetuximab

Cetuximab IV will be administered as per schedule specified in the respective arm.

DRUG

Atezolizumab

Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.

DRUG

Tiragolumab

Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.

DRUG

SY-5609

SY-5609 will be administered by mouth as per schedule specified in the respective arm.

DRUG

Divarasib

Divarasib will be administered orally as per schedule specified in the respective arms.

DRUG

FOLFOX

FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.

DRUG

FOLFIRI

FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.

DIAGNOSTIC_TEST

FoundationOne®Liquid CDx

FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-22
Primary Completion
2030-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Germany
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929223 on ClinicalTrials.gov