A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Launched by BLOSSOMHILL THERAPEUTICS · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BH-30643 for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic mutations known as EGFR or HER2 mutations. The trial is in its early stages, where researchers aim to find the right dose of the medication and see how well it works. Participants will take BH-30643 capsules by mouth twice a day for 21 days at a time, and the study will help determine not only the safety of the drug but also how effective it is in shrinking tumors.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with advanced NSCLC that has the required genetic mutations. They should have already tried standard treatments and have at least one measurable tumor outside of the brain. Additionally, they should be in good overall health and have a life expectancy of at least three months. Those who have had other cancers recently, certain unresolved health issues, or are participating in other clinical studies may not be able to join. Overall, this trial offers hope for patients with specific types of lung cancer to explore a new treatment option.

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Eligibility 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.