drugset
drugset / Trial / NCT04929223

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

NCT04929223 ↗

Phase 1 Recruiting 542 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-22
Primary completion
2030-08-31
Completion
2030-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1680 mg Intravenous
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 400 mg/m2 Intravenous
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Divarasib Small molecule — Oral
Subject Inavolisib Small molecule 9 mg Oral
Subject SY-5609 Small molecule 3 mg Oral
Subject SY-5609 Small molecule 4 mg Oral
Subject SY-5609 Small molecule 5 mg Oral
Subject SY-5609 Small molecule 6 mg Oral
Subject SY-5609 Small molecule 7 mg Oral
Subject SY-5609 Small molecule 10 mg Oral
Subject Tiragolumab Monoclonal antibody 600 mg Intravenous
Background Irinotecan Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous
Background Oxaliplatin Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous

Indications

colorectal cancer