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)
Hoffmann-La Roche
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Inform…
Interventions
- DrugInavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.
- DrugBevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
- DrugCetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
- DrugAtezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
- DrugTiragolumab
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
- DrugSY-5609
SY-5609 will be administered by mouth as per schedule specified in the respective arm.
Locations (76)
- UAB Comprehensive Cancer CenterBirmingham, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- City of Hope Comprehensive Cancer CenterDuarte, California
- cCareEncinitas, California
- USC Norris Cancer CenterLos Angeles, California
- Cedars-Sinai Medical CenterLos Angeles, California