This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.
Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).
Have at least one lesion, not previously irradiated that can be accurately measured per RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has received prior therapy with an anti-4-1BB(CD137) agent.
Known active CNS metastases and/or carcinomatous meningitis.
Known additional malignancy that is progressing or has required active treatment.
History of chronic liver disease or evidence of hepatic cirrhosis.
Hanmi Pharmaceutical Company Limited
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator