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RecruitingLast updated: 16 February 2026

SOLARA: A Study of a new targeted therapy (BH-30643) in people with locally advanced or metastatic NSCLC (Non-small Cell Lung Cancer) harboring EGFR and/or HER2 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

SOLARA

Clinical summary

Summary

This study aims to evaluate a new drug BH-30643-01 in people 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 is divided into two phases. Phase 1 will determine the recommended Phase 2 dose. Phase 2 will further evaluate the antitumor efficacy and safety in different participants. Each participant will take BH-30643 (10mg or 40mg capsules) orally twice daily based on their assigned dose levels.

Conditions

This trial is treating people with locally advanced or metastatic NSCLC harboring EGFR and/or HER2 mutations (SOLARA)

Eligibility

Inclusion

  • ≥ 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BlossomHill Therapeutics

Scientific Title

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)

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