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 (Sep 2026). This Phase 1/2 trial studies multiple treatments including BH-30643 and BH-30643 combo therapy with Carboplatin/Pemetrexed for nsclc (advanced non-small cell lung cancer).
Treatment: BH-30643 · BH-30643 combo therapy with Carboplatin/Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation in kinase domain of exons 18, 19, 20, or 21
EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21
Required: HER2 (ERBB2) mutation in kinase domain of exons 18, 19, 20, or 21
EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21
Excluded: MET amplification
Known other oncogenic driver alterations (eg, moderate or high MET amplification)
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Kidney function
Liver 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.
Does this trial require EGFR?
Yes, EGFR mutation in kinase domain of exons 18, 19, 20, or 21 is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 mutation in kinase domain of exons 18, 19, 20, or 21 is a required biomarker for enrollment.
Are patients with MET alterations eligible?
No. MET amplification is an exclusion criterion.
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