This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period
Timeframe: Up to 28 days after Day 1, Cycle 1
Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Timeframe: From initiation of the first dose of BNT314 + BNT327 until 90 days after last dose of investigational medicinal product (IMP)
Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Timeframe: From initiation of the first dose of BNT314 + BNT327 until 90 days after last dose of IMP
Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort
Timeframe: Up to 42 days after Day 1, Cycle 1
Phase I - Part B: Occurrence of TEAEs and TRAEs
Timeframe: From initiation of the first dose of BNT314 + BNT327 + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Timeframe: From initiation of the first dose of BNT314 + BNT327 + SoC chemotherapy until 90 days after last dose of IMP
BioNTech clinical trials patient information
Phase I - Part B: Objective response rate (ORR)
Timeframe: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase II - Part C: Progression free survival
Timeframe: From the time of initiation of the first dose of IMP to end of study, up to 57 months