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.
Single group
BI1206
DrugBI-1206 administrated either IV or SC every third week. Pembrolizumab 200mg administered IV every third week as a fixed dose will be used in Phase 1 and IIa. The mTPI2 Design will be used for both the IV and SC cohorts. ivRP2D and scRP2D to be used in Phase
Documentation of AEs and SAEs, clinically significant laboratory parameters, and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration
Assess the safety and tolerability profile of increasing doses of BI-1206, administered IV or SC, in combination with pembrolizumab in subjects with advanced solid tumors
DLT occurrence; determination of signal-seeking dose, the MTD or maximum administered dose of BI-1206 in Phase 1, based on the mTPI-2 design
In Phase 1, identify DLTs, determine the MTD, and select a signal-seeking Phase 2a dose of BI-1206 given via IV infusion or SC injection in combination with pembrolizumab (administered at the standard dose of 200 mg every 3 weeks) to subjects with advanced solid tumors who are experiencing disease progression and have been previously treated with anti-PD-1 or anti- PD-L1 antibodies
Determination of standard PK parameters (i.e., AUC, Cmax, Tmax, and terminal half-life [t½]) for BI-1206
Study the PK profile of BI-1206 administered IV or SC in combination with pembrolizumab in subjects with advanced solid tumors
Measurement of ADA response to BI-1206.
Assess the immunogenicity of BI-1206, administered IV or SC, in subjects with advanced solid tumors, when given in combination with pembrolizumab.
Measurement of CD32b receptor occupancy on B cells.
Evaluate the effect of BI-1206 IV or SC when administered in combination with pembrolizumab on CD32b receptor occupancy on B cells in subjects with advanced solid tumors.
Assessment of best disease responses according to Immunological Response Evaluation Criteria in Solid Tumors (iRECIST).
Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with pembrolizumab, 8 weeks after first dose of BI-1206 (i.e., the Week 9 Visit), including follow-up confirmation for progressive disease (PD), in subjects with advanced solid tumors
Measurement of progression free survival.
Assess the duration of clinical response to BI-1206 administered IV or SC in combination with pembrolizumab.
Measurement of duration of objective response and objective response rate
Duration of response: Time-to-event estimates will be generated using the Kaplan-Meier method. Objective response rate: ORR is defined as the percentage of subjects who achieved CR or PR.
Measurement of peripheral blood B-lymphocyte counts
Evaluate the effect of BI-1206 administered in combination with pembrolizumab on the depletion of peripheral blood B-lymphocytes in subjects with advanced solid tumors
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BioInvent International AB
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
