Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced or Metastatic Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT06724016
- Run by
- Hanmi Pharmaceutical Company Limited
- People needed
- 292
- Starts
- 2024-12-11
- Expected to finish
- 2031-07-01
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Severance Hospital — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Asan Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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