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

Sponsor
Biotheus Inc.
Study ID
NCT07133750
Phase
PHASE2
Status
Recruiting
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Conditions

  • CRC (Colorectal Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    IV infusion
  • Chemotherapy Regimen 1 — DRUG
    IV infusion
  • Chemotherapy Regimen 2 — DRUG
    Oral administration and IV infusion
  • Chemotherapy Regimen 3 — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Aug 21, 2025
Start date
Aug 19, 2025
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy regimen 1 group - PM8002 Dose 1 + chemotherapy regimen 1
    Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
  • Experimental: Chemotherapy regimen 1 group - PM8002 Dose 2 + chemotherapy regimen 1
    Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 1 via intravenously (IV) Q2W until progression.
  • Experimental: Chemotherapy regimen 2 group - PM8002 Dose 1 + chemotherapy regimen 2
    Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
  • Experimental: Chemotherapy regimen 2 group - PM8002 Dose 2 + chemotherapy regimen 2
    Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 2 via intravenously (IV) and oral administration (PO) Q3W until progression.
  • Experimental: Chemotherapy regimen 3 group - PM8002 Dose 1 + chemotherapy regimen 3
    Subjects will be administered with PM8002 (Dose 1) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.
  • Experimental: Chemotherapy regimen 3 group - PM8002 Dose 2 + chemotherapy regimen 3
    Subjects will be administered with PM8002 (Dose 2) plus chemotherapy regimen 3 via intravenously (IV) Q2W until progression.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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