Actively Recruiting
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-03-11
245
Participants Needed
10
Research Sites
209 weeks
Total Duration
On this page
Sponsors
H
Hanmi Pharmaceutical Company Limited
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable with no available standard therapy
- PD-L1 positive expression with Tumor Proportion Score 651% or Combined Positive Score 651
- Have at least one lesion not previously irradiated that can be accurately measured per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age 18 years or older (or country's legal age of majority if above 18 years)
- Adequate hematologic and liver function
You will not qualify if you...
- Prior therapy with an anti-4-1BB (CD137) agent
- Known active central nervous system metastases or carcinomatous meningitis
- Known additional malignancy that is progressing or requires active treatment
- History of chronic liver disease or evidence of hepatic cirrhosis
- History of severe toxicities from prior immunotherapy
- Ongoing or suspected autoimmune disease
- Known active and significant bacterial, fungal, or viral infection including HIV/AIDS or immunocompromised status
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
The START Center for Cancer Care - Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
4
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Withdrawn
5
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
7
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
8
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
9
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
10
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
Y
Young Su (Bobby) Noh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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