A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (NCT06706076)
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)
🩺 Plain-English Summary (8th-Grade Level)
This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy. Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital - Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (42 Sites)
Showing the first 25 of 42 sites.
- Mayo Clinic Hospital - Arizona — Phoenix, Arizona
- The Regents of the University of California - Irvine, CA Campus — Irvine, California
- UC San Diego Moores Cancer Center — La Jolla, California
- University of California, Davis Comprehensive Cancer Center — Sacramento, California
- Stanford University Medical Center — Stanford, California
- Yale University - Cancer Center — New Haven, Connecticut
- Georgetown University Medical Center — Washington D.C., District of Columbia
- Mayo Clinic - Florida — Jacksonville, Florida
- Sarah Cancer Research Institution - Florida Cancer Specialist — Orlando, Florida
- Moffitt Cancer Center — Tampa, Florida
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Health — Detroit, Michigan
- Mayo Clinic Hospital - Rochester, MN — Rochester, Minnesota
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Duke Cancer Institute — Durham, North Carolina
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Sarah Cannon Research Institute, LLC — Nashville, Tennessee
- The University of Texas - M.D. Anderson Cancer Center — Houston, Texas
- NEXT Virginia — Fairfax, Virginia
- Fred Hutchinson Cancer Center — Seattle, Washington
- Austin Health — Heidelberg, Victoria
📞 Contact the Study Coordinator
Phone: (858) 732-3880
Email: clinicaltrials@bhtherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.