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Study of BH3120 Alone or With Pembrolizumab for Advanced Solid Tumors

This study is testing BH3120, alone or with pembrolizumab, for people with advanced or metastatic (spread to other parts of the body) solid tumors. Researchers want to understand the safety and side effects of these treatments. They will also look at how well the treatments work. You may be able to join if you have a solid tumor that has spread or cannot be removed by surgery, and for which there is no standard treatment. Your tumor must also show a certain level of PD-L1, a protein that can be targeted by immunotherapy. The study is currently recruiting about 245 participants.

Study design
This is a Phase 1, First-in-Human study that will first find the right dose of BH3120, then test its effectiveness in specific groups of patients.
What's involved
BH3120 and pembrolizumab (if applicable) are given as intravenous (IV) infusions on Day 1 of every 3-week treatment cycle.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored throughout the study until 90 days after your last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06234397

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hanmi Pharmaceutical Company Limited
~245 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:BH3120pembrolizumab

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Measured over Throughout the study until end of safety follow-up period (90 days after the last treatment)
+1 more outcome measured

Conditions

Advanced or Metastatic Solid Tumors

Explore related trials

Solid NeoplasmProgrammed Cell Death 1 Ligand 1

Where it's being run

10 sites across 6 states
South Korea4
Texas2
Florida1
Michigan1
Ohio1
Gyeonggi-do1

Who to contact

Hyunmin (Dan) Lee
[email protected]
82-2-410-0470
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.Throughout the study until end of safety follow-up period (90 days after the last treatment)

    To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration

  • Incidence and nature of DLTsAt the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part

    To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration