Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
Start Date
12/11/2024
Completion Date
7/1/2031
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HM16390
pembrolizumab
Conditions
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea