A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Start Date
1/9/2025
Completion Date
7/31/2029
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.
Detailed Description
BH-30643 is a novel, orally available, non-covalent, macrocyclic, mutant selective OMNI-EGFR inhibitor that targets a broad diversity of mutations in the EGFR kinase domain. These include EGFR classical mutations (e.g., ex19del and L858R) as well as less common (atypical) mutations (including G719X, S768I, L861Q, E709X, and beyond). BH-30643 also overcomes a variety of mutations which can cause resistance to previously approved EGFR TKIs (including both C797S and T790M). BH-30643 was designed to be selective over wildtype EGFR and HER2.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BH-30643
BH-30643
Conditions
Locations
Mayo Clinic Hospital - Arizona
Phoenix, Arizona 85054
United States
The Regents of the University of California - Irvine, CA Campus
Irvine, California 92697
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Stanford University Medical Center
Stanford, California 94305
United States
Yale University - Cancer Center
New Haven, Connecticut 06520
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Mayo Clinic - Florida
Jacksonville, Florida 32224
United States
Sarah Cancer Research Institution - Florida Cancer Specialist
Orlando, Florida 32827
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois 60611
United States
Massachusetts General Hospital
Boston, Massachusetts 02214
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Mayo Clinic Hospital - Rochester, MN
Rochester, Minnesota 55905
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Institute
Durham, North Carolina 27710
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107
United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee 37203
United States
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Austin Health
Heidelberg, Victoria 3084
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Cross Cancer Insitute
Edmonton, Alberta T6G1Z2
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C4
Canada
Prince of Wales Hospital
Shatin, New Territories
Hong Kong
Queen Mary Hospital
Hong Kong,
Hong Kong
National Cancer Center Hospital East
Kashiwa, Chiba 227-8577
Japan
Kindai University Hospital
Osakasayama-shi, Osaka
Japan
National Cancer Center Hospital
Tsukiji, Tokyo
Japan
Sarawak General Hosital
Kuching, Sarawak 93586
Malaysia
National University Hospital
Kent Ridge, 119074
Singapore
National Cancer Centre - Singapore
Singapore, 168583
Singapore
Seoul National University Hospital
Seoul, 03080
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351'
South Korea
Taichung Veterans General Hospital
Taichung, 407219
Taiwan
National Taiwan University Cancer Center
Taipei,
Taiwan
National Taiwan University Hospital
Taipei,
Taiwan