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New hope for lung cancer: targeted drug BH-30643 enters human trials

NCT ID NCT06706076

Disease control Sponsor: BlossomHill Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 4 times

Summary

This study tests a new drug, BH-30643, in adults with advanced non-small cell lung cancer that has certain gene changes (EGFR or HER2 mutations). The goal is to find a safe dose and see if the drug can shrink tumors. About 266 people will take part across multiple locations.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 675 people

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

Started

Jan 2025

Expected to finish

Jul 2029

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.

Inclusion Criteria: * ≥ 18 years or legal adult. * Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. * Has at least 1 measurable target extracranial lesion according to RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status ≤ 1. * Has a life expectancy of ≥ 3 months. * Has adequate hematologic, hepatic, and renal function. * The above are a summary; other Inclusion Criteria details may apply. Exclusion Criteria: * History of any concurrent malignancy within the previous 2 years. * Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.). * Unresolved toxicities from prior therapies. * Any significant and uncontrolled medical condition, such as infection. * Active or history of interstitial lung disease from any cause * Clinically significant cardiovascular event within 6 months or significant history of major organ. * The above are a summary; other Exclusion Criteria details may apply.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

NSCLC (advanced non-small cell lung cancer)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G1Z2, Canada

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Kindai University Hospital

    RECRUITING

    Osakasayama-shi, Osaka, Japan

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02214, United States

  • Mayo Clinic - Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Hospital - Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital - Rochester, MN

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • National Cancer Center Hospital

    RECRUITING

    Tsukiji, Tokyo, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 227-8577, Japan

  • National Cancer Centre - Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • National Taiwan University Cancer Center

    RECRUITING

    Taipei, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • National University Hospital

    RECRUITING

    Kent Ridge, 119074, Singapore

  • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    RECRUITING

    Shatin, New Territories, Hong Kong

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Sarah Cancer Research Institution - Florida Cancer Specialist

    RECRUITING

    Orlando, Florida, 32827, United States

  • Sarah Cannon Research Institute, LLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarawak General Hospital

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94305, United States

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • The Regents of the University of California - Irvine, CA Campus

    RECRUITING

    Irvine, California, 92697, United States

  • The University of Texas - M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California, Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • Yale University - Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.