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)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 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.
Locations
United States
Arizona
Mayo Clinic Hospital - Arizona
RECRUITING
Phoenix
California
The Regents of the University of California - Irvine, CA Campus
RECRUITING
Irvine
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
University of California, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Mayo Clinic - Florida
RECRUITING
Jacksonville
Sarah Cancer Research Institution - Florida Cancer Specialist
RECRUITING
Lake Mary
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Mayo Clinic Hospital - Rochester, MN
RECRUITING
Rochester
Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center
RECRUITING
Philadelphia
Tennessee
Sarah Cannon Research Institute, LLC
RECRUITING
Nashville
Texas
The University of Texas - M.D. Anderson Cancer Center
RECRUITING
Houston
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
Australia
Austin Health
RECRUITING
Heidelberg
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Canada
Cross Cancer Insitute
RECRUITING
Edmonton
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Shatin
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kindai University Hospital
RECRUITING
Osakasayama-shi
National Cancer Center Hospital
RECRUITING
Tsukiji
Malaysia
Sarawak General Hosital
RECRUITING
Kuching
Singapore
National University Hospital
RECRUITING
Kent Ridge
National Cancer Centre - Singapore
RECRUITING
Singapore
Taiwan
National Taiwan University Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Sponsor Contact
clinicaltrials@bhtherapeutics.com
(858) 732-3880
Time Frame
Start Date:2025-01-09
Estimated Completion Date:2029-07-31
Participants
Target number of participants:266
Treatments
Experimental: Phase 1 Dose Escalation and Expansion
* BH-30643 monotherapy for dose escalation~* BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data~* BH-30643 twice daily oral dosing
Experimental: Phase 2
BH-30643 administered at the RP2D dose determined in Phase 1