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

RecruitingPhase 1Ages 18 Years - anyAllHanmi Pharmaceutical Company Limited
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • BH3120
  • pembrolizumab
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Where

10 sites
Moffitt Cancer Center
Tampa, United States
The START Center for Cancer Care - Midwest
Grand Rapids, United States
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, United States
Mary Crowley Cancer Research
Dallas, United States
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
San Antonio, United States
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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