Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb 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 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.
Key facts
- Study ID
- NCT06234397
- Run by
- Hanmi Pharmaceutical Company Limited
- People needed
- 245
- Starts
- 2023-12-28
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Samsung Medical Center — Seoul, South Korea (enrolling)
- The START Center for Cancer Care - Midwest — Grand Rapids, Michigan, United States (enrolling)
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center — Cincinnati, Ohio, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center — San Antonio, Texas, United States (enrolling)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Severance Hospital — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Mary Crowley Cancer Research — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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