Actively Recruiting
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Led by BlossomHill Therapeutics · Updated on 2026-04-24
266
Participants Needed
41
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older or legal adult
- Diagnosed with locally advanced or metastatic NSCLC with EGFR or HER2 kinase domain mutations
- Have received standard therapies prior to this study
- Have at least one measurable target extracranial lesion by RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Adequate hematologic, liver, and kidney function
You will not qualify if you...
- History of any other cancer within the past 2 years
- Known other oncogenic driver alterations or histological transformations
- Unresolved side effects from previous treatments
- Any serious uncontrolled medical condition such as infection
- History of interstitial lung disease
- Significant cardiovascular event within past 6 months or major organ history
- Currently receiving investigational therapy in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 41 locations
1
Mayo Clinic Hospital - Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
The Regents of the University of California - Irvine, CA Campus
Irvine, California, United States, 92697
Actively Recruiting
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
4
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
5
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
6
Yale University - Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Sarah Cancer Research Institution - Florida Cancer Specialist
Orlando, Florida, United States, 32827
Actively Recruiting
10
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
11
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, United States, 60611
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Actively Recruiting
13
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
16
Mayo Clinic Hospital - Rochester, MN
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
18
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
19
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
20
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
21
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
22
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
23
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
24
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
25
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
26
Cross Cancer Insitute
Edmonton, Alberta, Canada, T6G1Z2
Actively Recruiting
27
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
28
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Actively Recruiting
29
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
30
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 227-8577
Actively Recruiting
31
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Actively Recruiting
32
National Cancer Center Hospital
Tsukiji, Tokyo, Japan
Actively Recruiting
33
Sarawak General Hosital
Kuching, Sarawak, Malaysia, 93586
Actively Recruiting
34
National University Hospital
Kent Ridge, Singapore, 119074
Actively Recruiting
35
National Cancer Centre - Singapore
Singapore, Singapore, 168583
Actively Recruiting
36
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
37
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
38
Samsung Medical Center
Seoul, South Korea, 06351'
Actively Recruiting
39
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
40
National Taiwan University Cancer Center
Taipei, Taiwan
Actively Recruiting
41
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
S
Sponsor Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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