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.
Parallel
BH3120
DrugBH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
pembrolizumab
DrugFixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Incidence and nature of DLTs
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
The maximum serum concentration (Cmax)
To evaluate PK profile upon BH3120 administration
The time to reach Cmax (Tmax)
To evaluate PK profile upon BH3120 administration
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
To evaluate PK profile upon BH3120 administration
The AUC during the dosing interval (AUCtau)
To evaluate PK profile upon BH3120 administration
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Hanmi Pharmaceutical Company Limited
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
