A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
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.
Checked against the public recordLast updated Aug 5, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- BlossomHill Therapeutics
- Interventions being studied
- Drug: BH-30643; Drug: BH-30643 combo therapy with Carboplatin/Pemetrexed; Drug: BH-30643
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic Hospital - ArizonaPhoenix, Arizona
- The Regents of the University of California - Irvine, CA CampusIrvine, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- Stanford University Medical CenterStanford, California
- Yale University - Cancer CenterNew Haven, Connecticut
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Mayo Clinic - FloridaJacksonville, Florida
- Sarah Cancer Research Institution - Florida Cancer SpecialistOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2026. Always confirm current availability with the study team.