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A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Sponsor: BlossomHill Therapeutics
Summary
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. 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.
Official 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2025-01-09
Completion Date
2029-07-31
Last Updated
2026-02-09
Healthy Volunteers
No
Interventions
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.
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.
Locations (38)
Mayo Clinic Hospital - Arizona
Phoenix, Arizona, United States
The Regents of the University of California - Irvine, CA Campus
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale University - Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Sarah Cancer Research Institution - Florida Cancer Specialist
Lake Mary, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Mayo Clinic Hospital - Rochester, MN
Rochester, Minnesota, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Cross Cancer Insitute
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
National Cancer Center Hospital
Tsukiji, Tokyo, Japan
Sarawak General Hosital
Kuching, Sarawak, Malaysia
National University Hospital
Kent Ridge, Singapore
National Cancer Centre - Singapore
Singapore, Singapore
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Cancer Center
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan