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NCT06234397PHASE1Recruiting

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

Hanmi Pharmaceutical Company Limited

Start Date

12/28/2023

Completion Date

1/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BH3120

DRUG

pembrolizumab

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Conditions

Advanced or Metastatic Solid Tumors

Locations

Moffitt Cancer Center

Tampa, Florida 33612

United States

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan 49546

United States

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio 45219

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center

San Antonio, Texas 78229

United States

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea