Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, 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 RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.

NCT Number	NCT06724016
Lead Sponsor	Hanmi Pharmaceutical Company Limited Collaborators: Merck Sharp & Dohme LLC
Conditions	Advanced or Metastatic Solid Tumors
Enrollment	292 participants
Start Date	2024-12-11
Primary Completion	2031-07 (estimated)
Study Completion	2031-07 (estimated)
Updated on ClinicalTrials.gov	2025-12-17