NCT07133750

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

A Phase II, Multicenter, Open Label, Parallel Cohort Clinical Trial to Evaluate the Efficacy and Safety of PM8002 (BNT327) in Combination With Chemotherapy in First Line MSS or MSI-L/pMMR Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multicenter, randomized, open-label study design is used, with a planned enrollment of 40 participants, 30 in the PM8002 (BNT327)+ chemotherapy regimen 1 group and 10 in the PM8002 (BNT327)+ chemotherapy regimen 2 group. The investigators make the decision on which chemotherapy regimen to be used in the participants. After combined chemotherapy regimen is confirmed, participants will be randomized to one of two dose levels of PM8002(BNT327) plus chemotherapy.

Conditions

• CRC (Colorectal Cancer)

Interventions

Type	Name	Description
DRUG	PM8002	IV infusion
DRUG	Chemotherapy Regimen 1	IV infusion
DRUG	Chemotherapy Regimen 2	Oral administration and IV infusion

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2029-08-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: China