Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

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.

NCT Number	NCT06234397
Lead Sponsor	Hanmi Pharmaceutical Company Limited Collaborators: Merck Sharp & Dohme LLC
Conditions	Advanced or Metastatic Solid Tumors
Enrollment	245 participants
Start Date	2023-12-28
Primary Completion	2027-08 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-12