Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Is willing and able to provide written informed consent for the trial.
Is ≥18 years of age on day of signing informed consent.
Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study, other than as premedication.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients.
Has cardiac or renal amyloid light-chain (AL) amyloidosis.
BioInvent International AB
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator