OncoMatch/Clinical Trials/NCT06706076
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Is NCT06706076 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including BH-30643 and BH-30643 for nsclc (advanced non-small cell lung cancer).
Treatment: BH-30643 · BH-30643 — 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. 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR classical mutation
EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
Required: EGFR atypical mutation
EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
Required: EGFR exon20 insertion
EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
Required: EGFR activating mutation
EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
Required: EGFR acquired resistance mutation
EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
Required: HER2 (ERBB2) mutation in the kinase domain of exons 18, 19, 20, or 21
HER2 mutations in the kinase domain of exons 18, 19, 20, or 21
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapies
Had received standard therapies
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Has adequate hematologic, hepatic, and renal function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital - Arizona · Phoenix, Arizona
- The Regents of the University of California - Irvine, CA Campus · Irvine, California
- UC San Diego Moores Cancer Center · La Jolla, California
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- Stanford University Medical Center · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06706076 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received standard therapies.
Does this trial require EGFR?
Yes, EGFR classical mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR atypical mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR exon20 insertion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify