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Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Sponsor: Hanmi Pharmaceutical Company Limited
Summary
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.
Official title: A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2023-12-28
Completion Date
2028-01
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
BH3120
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
pembrolizumab
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Locations (10)
Moffitt Cancer Center
Tampa, Florida, United States
The START Center for Cancer Care - Midwest
Grand Rapids, Michigan, United States
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
San Antonio, Texas, United States
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea