A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).
• Have unresectable histologically confirmed adenocarcinoma of the colon or rectum.
• Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing.
• Have measurable disease defined by RECIST v1.1.
• Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival tumor tissue (less than 2 years prior treatment).
• Have Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Have a life expectancy of ≥12 weeks.
• Have an adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol.
• Have had an adequate previous treatment washout period before randomization/enrollment as defined in the protocol.
• Have histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.
• Have progressed following first-line chemotherapy as specified in the protocol.
• Have not received prior systemic therapy for MSS/pMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.
⁃ Other cohort-specific inclusion criteria apply.