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

What this Trial Is About

Researchers are evaluating the safety and effectiveness of various targeted therapies and immunotherapy combinations in adults with metastatic colorectal cancer mCRC whose tumors show specific biomarkers. This open-label, exploratory Phase 1 study aims to understand how these treatments work in different patient subgroups based on their tumors genetic characteristics. Participants are assigned to treatment groups depending on their biomarker test results. Participants receive different combinations of drugs such as inavolisib, cetuximab, bevacizumab, atezolizumab, tiragolumab, SY-5609, divarasib, FOLFOX, and FOLFIRI. Treatments may be given orally or by intravenous infusion following specific schedules, with cycles lasting 21 or 28 days depending on the regimen. Some treatment arms are closed, while others are active or recruiting participants. Throughout the study, participants undergo regular assessments including tumor measurements to evaluate response rates. Researchers monitor safety by tracking adverse events and measure drug levels in the blood at set intervals. The primary outcome is the objective response rate over approximately 84 months, with secondary outcomes including duration of response, disease control rate, and recommended doses for some drug combinations. The study lasts several years, with ongoing monitoring of participants health and tumor status.

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