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Clinical Trials in the USA / NCT06706076
Recruiting Phase 1/2

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

NCT06706076 · tracked via the Priya Life Science USA tracker
Sponsor
BlossomHill Therapeutics
Phase
Phase 1/2
Started
2025-01-09
Last updated
2026-08-05

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

BH-30643BH-30643 combo therapy with Carboplatin/PemetrexedBH-30643

BH-30643: BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets. Subjects will take BH-30643 orally depending on their dose level assignment.

BH-30643 combo therapy with Carboplatin/Pemetrexed: BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets in combo therapy with Carboplatin/Pemetrexed. Subjects will take BH-30643 orally depending on their dose level assignment. Carboplatin/Pemetrexed will be administered according to standard of care

BH-30643: BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment

Study summary

This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.

Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy.

Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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).

Trial sites (42)

FacilityCityRegionStatus
Mayo Clinic Hospital - Arizona Phoenix Arizona Recruiting
The Regents of the University of California - Irvine, CA Campus Irvine California Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
University of California, Davis Comprehensive Cancer Center Sacramento California Recruiting
Stanford University Medical Center Stanford California Recruiting
Yale University - Cancer Center New Haven Connecticut Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
Mayo Clinic - Florida Jacksonville Florida Recruiting
Sarah Cancer Research Institution - Florida Cancer Specialist Orlando Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion Chicago Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Health Detroit Michigan Recruiting
Mayo Clinic Hospital - Rochester, MN Rochester Minnesota Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke Cancer Institute Durham North Carolina Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center Philadelphia Pennsylvania Recruiting
Sarah Cannon Research Institute, LLC Nashville Tennessee Recruiting
The University of Texas - M.D. Anderson Cancer Center Houston Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Austin Health Heidelberg Victoria Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Prince of Wales Hospital Shatin New Territories Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
National Cancer Center Hospital East Kashiwa Chiba Recruiting
Kindai University Hospital Osakasayama-shi Osaka Recruiting
National Cancer Center Hospital Tsukiji Tokyo Recruiting
Sarawak General Hospital Kuching Sarawak Recruiting
National University Hospital Kent Ridge Singapore Recruiting
National Cancer Centre - Singapore Singapore Singapore Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Taichung Veterans General Hospital Taichung Taiwan Recruiting

+ 2 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706076 on ClinicalTrials.gov ↗ ← All trials in the USA