Recruiting
Phase 1

BH3120 & Pembrolizumab

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT06234397

Conditions

Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BH3120

pembrolizumab

Study Details

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Study ID

NCT06234397

Start date

Dec 28, 2023

Status verified date

Aug, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

245 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BH3120

Arm A: BH3120 Monotherapy

experimental: BH3120 + pembrolizumab

Arm B: BH3120 in combination with pembrolizumab

Interventions

BH3120

BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle

pembrolizumab

Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Primary outcome measure

  • Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. [ Time Frame: Throughout the study until end of safety follow-up period (90 days after the last treatment) ]
  • Incidence and nature of DLTs [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part ]

Central Contacts and Locations

Central contacts

Hyunmin (Dan) Lee

82-2-410-0470Hyunmin.lee0607@hanmi.co.kr

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

The START Center for Cancer Care - Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

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

Recruiting

Cincinnati, Ohio, United States, 45219

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

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2026-08-12.