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A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
NCT06706076 · BlossomHill Therapeutics
In plain English
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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)
About this study
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
Inclusion Criteria:
* ≥ 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.
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.
* History of interstitial lung disease from any cause
* Clinically significant cardiovascular event within 6 months or significant history of major organ.
* Actively receiving investigational therapy(ies) in another clinical study. \*The above are a summary; other Exclusion Criteria details may apply.
Study design
Enrollment target: 266 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-09
Estimated completion: 2029-07-31
Last updated: 2026-02-09
Interventions
Drug: BH-30643Drug: BH-30643
Primary outcomes
- • Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) (Within the first 21 days of the first dose of BH-30643.)
- • Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization) (Within 21 days of last participant dosed during Dose Expansion/Optimization.)
- • Objective Response Rate (ORR) (Phase 2) (Approximately 3 years after the first participant dosed.)
Sponsor
BlossomHill Therapeutics · industry
Contacts & investigators
ContactSponsor Contact · contact · clinicaltrials@bhtherapeutics.com · (858) 732-3880
All locations (38)
Mayo Clinic Hospital - ArizonaRecruiting
Phoenix, Arizona, United States
The Regents of the University of California - Irvine, CA CampusRecruiting
Irvine, California, United States
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
University of California, Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
Yale University - Cancer CenterRecruiting
New Haven, Connecticut, United States
Georgetown University Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Mayo Clinic - FloridaRecruiting
Jacksonville, Florida, United States
Sarah Cancer Research Institution - Florida Cancer SpecialistRecruiting
Lake Mary, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionRecruiting
Chicago, Illinois, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Mayo Clinic Hospital - Rochester, MNRecruiting
Rochester, Minnesota, United States
Thomas Jefferson University, Sidney Kimmel Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, LLCRecruiting
Nashville, Tennessee, United States
The University of Texas - M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Cross Cancer InsituteRecruiting
Edmonton, Alberta, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Prince of Wales HospitalRecruiting
Shatin, New Territories, Hong Kong
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Kindai University HospitalRecruiting
Osakasayama-shi, Osaka, Japan
National Cancer Center HospitalRecruiting
Tsukiji, Tokyo, Japan
Sarawak General HositalRecruiting
Kuching, Sarawak, Malaysia
National University HospitalRecruiting
Kent Ridge, Singapore
National Cancer Centre - SingaporeRecruiting
Singapore, Singapore
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Taiwan University Cancer CenterRecruiting
Taipei, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan