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 popu

Trial Details

NCT ID
NCT06706076
Phase
PHASE1 / PHASE2
Sponsor
BlossomHill Therapeutics
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • BH-30643
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Irvine, California, United States|33.66946,-117.82311
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility 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…
  • Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group Performance Status ≤ 1.

For full eligibility, visit ClinicalTrials.gov.

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