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

Trial status:Will Be Recruiting
Trial ID:
PM8002-B018C-CRC-R
NCT ID:
NCT07133750
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Biotheus Inc.
Will Be Recruiting

Trial 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.

Medical Condition
  • Unmapped
    • Trial Drug
  • PM8002
    • See more
  • Chemotherapy Regimen 1
  • Chemotherapy Regimen 2
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    40
    Estimated Trial Date
    Aug 2025 - Aug 2026

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria
    1. Signed informed consent form before any trial-related processes.
    2. Age ≥ 18 years male or female.
    3. Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC/AJCC staging system) that is not suitable for or cannot be radically resected surgically.
    4. Participants must not have dMMR or MSI-H.
    5. No prior systemic anti-tumor therapy for metastatic colorectal cancer.
    6. have adequate organ function.
    7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
    8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
    Exclusion criteria
    1. Received the following treatments or medications prior to starting study treatment:
      1. Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.
      2. Treatment with systemic glucocorticoids (prednisone \>10 mg/day or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to initiation of study treatment. Note: treatment with local, intraocular, intra-articular, intranasal, and inhaled glucocorticosteroids and short-term prophylactic use of glucocorticoids (e.g., to prevent allergy to contrast agent) are allowed.
    2. Have a major coagulation disorder or other evidence of significant bleeding risk.
    3. Adverse effects of prior antitumor therapy have not returned to a CTCAE 5.0 grade rating of ≤ grade 1
    4. Have a serious non-healing wound, ulcer, or bone fracture.
    5. History of abdominal fistula, gastrointestinal perforation, or abdominal abscess, history of gastrointestinal obstruction, or clinical signs of gastrointestinal obstruction within 6 months prior to initiation of study treatment.
    6. Severe uncontrollable intra-abdominal inflammation that requires clinical intervention, in the judgment of the investigator.
    7. Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.

    Trial Locations

    Location
    Status
    Location
    Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China, 510060
    Status