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RECRUITING Phase 1 ClinicalTrials.gov

Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Sponsor: Hanmi Pharmaceutical Company Limited • ClinicalTrials.gov ID: NCT06234397

Registry updated: 2026-09-25
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Description

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.

Interventions

  • BH3120 (Drug)
    BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
  • pembrolizumab (Drug)
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Eligibility 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 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.

Conditions

Advanced or Metastatic Solid Tumors

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record