Study of BNT314 With Pumitamig and Chemotherapy for Metastatic Colorectal Cancer A Phase 12 Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating new treatment combinations involving BNT314 and pumitamig alongside chemotherapy in people with metastatic colorectal cancer mCRC that is microsatellite stable or mismatch repair proficient. This study includes three parts Part A focuses on safety and dose escalation of BNT314 with pumitamig Part B assesses safety and dosing of BNT314 combined with pumitamig and standard chemotherapy in treatment-nafve or previously treated patients Part C tests effectiveness of these combinations compared to usual chemotherapy treatments. The study aims to see if these treatments can shrink tumors or slow cancer growth. Participants receive intravenous infusions of BNT314 and pumitamig, along with standard of care SoC chemotherapy, in various dose levels and combinations depending on the study part. Part A evaluates up to five dose levels of BNT314 and one or two doses of pumitamig. Part B uses optimized doses of BNT314 with pumitamig and one of two chemotherapy regimens. Part C compares the recommended BNT314 and pumitamig doses plus chemotherapy against other treatment combinations, including bevacizumab with chemotherapy or pumitamig with chemotherapy. Treatment continues until disease progression, intolerance, withdrawal, or study end. Participants undergo eligibility screening, then receive treatment for an average of 6 to 10 months. They are regularly monitored for safety and treatment effects, including tumor response and side effects, with assessments extending up to 57 months after starting treatment. After treatment ends, participants enter safety follow-up and long-term survival monitoring to track any lasting effects and overall outcomes. Randomization is used in Parts B and C to assign treatments by chance.

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer