Testing BH3120 alone or with pembrolizumab for advanced solid tumors
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
This study is testing a new treatment called BH3120, both alone and with another drug called pembrolizumab, to see if it can help people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hanmi Pharmaceutical Company Limited Industry-sponsored |
| Drugs / interventions | immunotherapy, pembrolizumab |
| Locations | 10 sites (Tampa, Florida and 9 other locations) |
| Trial ID | NCT06234397 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety and efficacy of BH3120, both as a standalone treatment and in combination with pembrolizumab, for patients with advanced or metastatic solid tumors. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD) and a dose-expansion phase to assess the potential efficacy of the treatment at the recommended dose. Participants will be monitored for safety, tolerability, pharmacokinetics, and overall response to the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed metastatic or unresectable solid tumors that express PD-L1 and have not received prior anti-4-1BB therapy.
Not a fit: Patients with active CNS metastases, chronic liver disease, or those who have experienced severe toxicities from prior immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have no available standard therapies.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is being explored for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Have a Histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is 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 of 18 years or older (or country's legal age of majority if the legal age was \>18 years) * Adequate Hematologic and liver function. Key Exclusion Criteria: * Has received prior therapy with an anti-4-1BB(CD137) agent. * Known active CNS metastases and/or carcinomatous meningitis. * Known additional malignancy that is progressing or has required active treatment. * History of chronic liver disease or evidence of hepatic cirrhosis. * History of severe toxicities associated with a prior immunotherapy. * Has ongoing or suspected autoimmune disease. * Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
Where this trial is running
Tampa, Florida and 9 other locations
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- The START Center for Cancer Care - Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center — Cincinnati, Ohio, United States (Recruiting)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Withdrawn)
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center — San Antonio, Texas, United States (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 (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Young Su (Bobby) Noh
- Email: 63forever@hanmi.co.kr
- Phone: 82-2-410-9277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.