NCT04929223

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

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 542 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-22
• Primary completion: 2030-08-31
• Completion: 2030-08-31
• First posted: 2021-06-18
• Last updated: 2026-03-31

Locations

74 sites across 11 countries: United States, Australia, Canada, Denmark, Germany, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study