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Phase I/II, randomized, multicenter clinical trial to investigate the efficacy and safety of BNT314 in combination with pumitamig and chemotherapy in participants with metastatic colorectal cancer.
THE MAIN OBJECTIVES OF THE STUDY ARE AS FOLLOWS: PART A (PHASE 1, SAFETY RUN-IN, DOSE ESCALATION): TO DETERMINE WHETHER BNT314 IN COMBINATION WITH PUMITAMIG CAN BE ADMINISTERED SAFELY WITHOUT CAUSING SERIOUS SIDE EFFECTS IN PARTICIPANTS. PART B (PHASE 1, DOSE OPTIMIZATION): TO ASSESS WHETHER BNT314 IN COMBINATION WITH PUMITAMIG AND STANDARD CHEMOTHERAPY IS SAFE FOR PARTICIPANTS AND TO DETERMINE THE APPROPRIATE DOSE OF BNT314 TO BE USED IN PART C. PART C (PHASE 2, RANDOMIZATION VERSUS STANDARD TREATMENT): TO EVALUATE HOW WELL THE TREATMENT WORKS WHEN BNT314 AND PUMITAMIG ARE ADMINISTERED IN COMBINATION WITH USUAL STANDARD CHEMOTHERAPY.
Technical Summary
- PHASE I/II, RANDOMIZED, MULTICENTER TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF BNT314 IN COMBINATION WITH PUMITAMIG AND CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC COLORECTAL CANCER.
- Code EudraCT: 2025-521768-36-00
- Protocol number: BNT314-02
- Promoter: BioNTech SE
- Molecule/Drug: BNT314
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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