Testing BH3120 alone or with pembrolizumab for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 prior immunotherapy, except for adequately controlled endocrine-related adverse events managed with hormone replacement therapy.
* 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 it's running

• 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
• 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

Study contacts

• Study coordinator: Hyunmin (Dan) Lee
• Email: Hyunmin.lee0607@hanmi.co.kr
• Phone: 82-2-410-0470

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.