Phase 1 Study of CBI-1214 T Cell Engager for Safety, Dosage, and Anti-Tumor Effects in Adults With Advanced or Metastatic MSSMSI-L Colorectal Cancer

What this Trial Is About

Researchers are evaluating CBI-1214, a bispecific T cell engager, in adults with advanced or metastatic Microsatellite Stable MSS or Microsatellite Instability Low MSI-L colorectal cancer who have already tried at least one standard systemic therapy. This Phase 1 trial focuses on studying the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214, which targets malignant colorectal cancer cells by linking T cells to them to promote tumor cell killing. Participants will receive escalating doses of CBI-1214 sequentially to determine the safest and most effective dose levels. After completing dose escalation, a recommended expansion dose will be selected for further study in a dose-expansion phase. This dosing approach aims to find the maximum tolerated dose and the optimal biological dose of CBI-1214 for treating this cancer type. During the study, participants will undergo monitoring for safety and tolerability over approximately 48 months. Researchers will also measure serum concentrations of CBI-1214 and evaluate responses such as overall response rate, duration of response, progression-free survival, time to response, clinical benefit rate, and overall survival. Tissue samples may be collected to support these evaluations. The trial follows participants until study completion in October 2029 to gather comprehensive data on the treatments effects.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer