NCT06706076 · BlossomHill Therapeutics
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
(SOLARA)
What this study is about
BH-30643-01 is a Phase 1/2, first-in-human, open label, gradually increasing doses and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
View original scientific description
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.
Interventions
DRUG
BH-30643
BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.
DRUG
BH-30643
BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.
Primary outcome measures
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Time frame: Within the first 21 days of the first dose of BH-30643.
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
Time frame: Within 21 days of last participant dosed during Dose Expansion/Optimization.
Determine the RP2D for Phase 2.
Objective Response Rate (ORR) (Phase 2)
Time frame: Approximately 3 years after the first participant dosed.
Determine ORR as assessed by Blinded Independent Central Review (BICR).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 significa
Where
- Phoenix, Arizona
- Irvine, California
- La Jolla, California
- Sacramento, California
- Stanford, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Orlando, Florida
- Tampa, Florida
- Chicago, Illinois
- Boston, Massachusetts
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations