Clinical Trial

PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Recruiting Phase 2

Summary

PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal cancer.

Protocol Amendment History 6 changes

critical Recruitment opened 2026-07-24

notable Enrollment increased: 40 -> 100 participants 2026-07-24

minor Trial arms changed: 4 -> 6 2026-07-24

notable Trial sites expanded: 1 -> 11 locations 2026-07-24

notable Primary completion pushed: 2026-08 -> 2027-05 2026-07-24

minor Completion pushed: 2029-08 -> 2030-05 2026-07-24

Trial Details

NCT Number	NCT07133750
Lead Sponsor	Biotheus Inc. Collaborators: BioNTech SE
Conditions	CRC (Colorectal Cancer)
Enrollment	100 participants
Start Date	2025-08-19
Primary Completion	2027-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-23