Status:
NOT_YET_RECRUITING
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Biotheus Inc.
Collaborating Sponsors:
BioNTech SE
Conditions:
CRC (Colorectal Cancer)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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/pM...
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)+ chemoth...
Eligibility Criteria
Inclusion
- Key
- Signed informed consent form before any trial-related processes.
- Age ≥ 18 years male or female.
- Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC/AJCC staging system) that is not suitable for or cannot be radically resected surgically.
- Participants must not have dMMR or MSI-H.
- No prior systemic anti-tumor therapy for metastatic colorectal cancer.
- have adequate organ function.
- 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.
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
- Key
Exclusion
- Received the following treatments or medications prior to starting study treatment:
- Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.
- 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.
- Have a major coagulation disorder or other evidence of significant bleeding risk.
- Adverse effects of prior antitumor therapy have not returned to a CTCAE 5.0 grade rating of ≤ grade 1
- Have a serious non-healing wound, ulcer, or bone fracture.
- 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.
- Severe uncontrollable intra-abdominal inflammation that requires clinical intervention, in the judgment of the investigator.
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07133750
Start Date
August 1 2025
End Date
August 1 2029
Last Update
August 21 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060