Actively Recruiting
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
Led by Hanmi Pharmaceutical Company Limited · Updated on 2026-03-11
245
Participants Needed
10
Research Sites
21 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
Researchers are evaluating BH3120 as a single agent and combined with pembrolizumab in patients with advanced or metastatic solid tumors that have no standard treatment options. This Phase 1, first-in-human study aims to assess the safety, tolerability, maximum tolerated dose (MTD), recommended dose (RD), pharmacokinetics (PK), and potential efficacy of BH3120 in these patients. The study includes dose-escalation and dose-expansion parts to find the appropriate dosing and evaluate treatment effects in specific tumor groups. Participants will receive BH3120 intravenously over 90 minutes on Day 1 of each 3-week cycle. Some participants will receive BH3120 alone, while others will receive it combined with pembrolizumab, which is given as a fixed 30-minute IV infusion also on Day 1 of each cycle. The dose-escalation phase determines the highest safe dose or recommended dose, and the expansion phase tests the treatment at this dose in different tumor types. During the study, participants will be monitored for adverse events, laboratory abnormalities, and dose-limiting toxicities, particularly in the first treatment cycle. Researchers will measure BH3120 blood levels and immune responses over time, assessing tumor response, disease control, progression-free survival, and duration of response for up to two to three years. Safety follow-up continues for 90 days after the last treatment. The total participation time varies based on treatment duration and disease status.
CONDITIONS
Brief 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 (Tumor Proportion Score ≥1% or Combined Positive Score ≥1)
- 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 legal age of majority in your country if over 18)
- Adequate hematologic and liver function
You will not qualify if you...
- Prior therapy with an anti-4-1BB (CD137) agent
- Known active CNS metastases and/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 clinically significant bacterial, fungal, or viral infection including HIV or AIDS-related illness
- Immunocompromised status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 to 3 years or until disease progression or discontinuation
Participants receive BH3120 alone or in combination with pembrolizumab through intravenous infusions every 3 weeks to treat advanced or metastatic solid tumors.
Infusions every 3 weeks
Duration - 90 days after the last treatment
Participants are monitored for safety and adverse events after completing treatment for up to 90 days.
Visits as needed for safety monitoring
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
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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