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A Study of BH-30643 for Advanced NSCLC with EGFR and/or HER2 Mutations

This study is testing a drug called BH-30643 in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific changes (mutations) in the EGFR or HER2 genes. BH-30643 is designed to target these mutations. You might be able to join if you are 18 or older, have NSCLC with these specific EGFR or HER2 mutations, and have already received standard treatments. The study will look at how safe BH-30643 is, how well your body handles it, and if it shrinks tumors. Researchers will also determine the best dose of BH-30643 to use in future studies. The study aims to see how many participants respond to the treatment, with this measurement taken about three years after the first participant starts.

Study design
This is an open-label, multi-center study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 266 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how many participants respond to the treatment approximately three years after the first participant starts.

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

NCT06706076

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Recruiting
PHASE1Ages 18+InterventionalTreatment
BlossomHill Therapeutics
~675 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:BH-30643BH-30643 combo therapy with Carboplatin/Pemetrexed

At a glance

Recruiting sites
42 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Measured over Within the first 21 days of the first dose of BH-30643.
+2 more outcomes measured

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

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Where it's being run

42 sites across 28 states
California4
Florida3
Massachusetts3
South Korea3
Taiwan3
New York2
Victoria2
Singapore2

Who to contact

Sponsor Contact
[email protected]
(858) 732-3880
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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.

Exclusion

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.

What this trial measures

  • Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)Within the first 21 days of the first dose of BH-30643.

    Assess dose-limiting toxicities (DLTs) as defined in the study protocol.

  • Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)Within 21 days of last participant dosed during Dose Expansion/Optimization.

    Determine the RP2D for Phase 2.

  • Objective Response Rate (ORR) (Phase 2)Approximately 3 years after the first participant dosed.

    Determine ORR as assessed by Blinded Independent Central Review (BICR).