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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years or legal adult.
* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
* 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.
* Active or history of interstitial lung disease from any cause
* Clinically significant cardiovascular event within 6 months or significant history of major organ.

  * The above are a summary; other Exclusion Criteria details may apply.

Where it's running

• Mayo Clinic Hospital - Arizona
  Phoenix, Arizona, United States Recruiting
• The Regents of the University of California - Irvine, CA Campus
  Irvine, California, United States Recruiting
• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Cedars-Sinai Cancer at Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Stanford University Medical Center
  Stanford, California, United States Recruiting

Study contacts

• Study coordinator: Sponsor Contact
• Email: clinicaltrials@bhtherapeutics.com
• Phone: (858) 732-3880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.