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

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.

Eligibility

Key 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.

Key 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.

Conditions2

Interventions4

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