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

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.