Home › Trials › NCT06706076

Treatment for advanced non-small cell lung cancer with specific mutations

A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)

PHASE1; PHASE2 · BlossomHill Therapeutics · NCT06706076

This study is testing a new oral medication called BH-30643 to see if it can safely help people with advanced non-small cell lung cancer that has specific mutations.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment266 (estimated)
Ages18 Years and up
SexAll
SponsorBlossomHill Therapeutics (industry)
Locations41 sites (Phoenix, Arizona and 40 other locations)
Trial IDNCT06706076 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of BH-30643, a novel oral medication, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR and/or HER2 mutations. The study is divided into two phases: Phase 1 focuses on determining the recommended dose and maximum tolerated dose of BH-30643, while Phase 2 assesses its anti-tumor activity and safety in specific patient cohorts. Participants will take the medication twice daily in 21-day cycles, and the study will also analyze pharmacokinetics and pharmacodynamics.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced NSCLC who have specific EGFR or HER2 mutations and have previously received standard therapies.

Not a fit: Patients with concurrent malignancies, unresolved toxicities from prior treatments, or other oncogenic driver alterations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with specific genetic mutations in NSCLC.

How similar studies have performed: Other studies targeting EGFR and HER2 mutations in NSCLC have shown promising results, indicating that this approach has potential based on previous successes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥ 18 years or legal adult.
* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with 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.
* Had received standard therapies.
* 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.
* History of interstitial lung disease from any cause
* Clinically significant cardiovascular event within 6 months or significant history of major organ.
* Actively receiving investigational therapy(ies) in another clinical study. \*The above are a summary; other Exclusion Criteria details may apply.

Where this trial is running

Phoenix, Arizona and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: NSCLC, Locally Advanced NSCLC, Metastatic NSCLC, Non-small Cell Lung Cancer, HER2 mutation, EGFR mutation, EGFR classical mutation, EGFR atypical mutation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.