Condition: Advanced or Metastatic Solid Tumors · Sponsor: Hanmi Pharmaceutical Company Limited
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.
This description comes directly from the study's public registry record.
Young Su (Bobby) Noh · 82-2-410-9277 · 63forever@hanmi.co.kr
Always discuss trial participation with your own doctor first.
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Karmanos Cancer Institute | Detroit, Michigan, United States | Not Yet Recruiting |
| Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do, South Korea | Recruiting |
| Seoul National University Hospital | Seoul, South Korea | Recruiting |
| Severance Hospital | Seoul, South Korea | Recruiting |
| Asan Medical Center | Seoul, South Korea | Active Not Recruiting |
| Samsung Medical Center | Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06724016