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New drug combo aims to shrink Hard-to-Treat tumors

NCT ID NCT06234397

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called BH3120, alone or with pembrolizumab, in adults with advanced solid tumors that have stopped responding to standard treatments. The main goals are to check safety, find the best dose, and see if the drug can shrink tumors. About 245 participants will take part across multiple countries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 245 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

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

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Mary Crowley Cancer Research

    WITHDRAWN

    Dallas, Texas, 75230, United States

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

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • The START Center for Cancer Care - Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

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