Actively Recruiting
A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of BH-30643 in Adults 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BH-30643, a new oral drug, in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR and/or HER2 mutations. This Phase 1/2, open-label study aims to understand the safety, tolerability, how the drug is processed by the body, and its initial anti-tumor effects. The study will also explore the best dose for further testing and how the drug performs in different patient groups based on mutation subtype and prior treatments. The study includes two main parts. Phase 1 focuses on finding the recommended dose and maximum tolerated dose of BH-30643 through dose escalation and expansion. Participants will take BH-30643 capsules orally, either 10 mg or 40 mg, with dosing schedules adjusted as needed. Phase 2 will use the recommended dose from Phase 1 to further evaluate the drug's anti-tumor activity and safety in specified patient groups. Both phases involve taking the drug twice daily by mouth. Participants will be closely monitored throughout the study. Researchers will assess side effects, blood levels of BH-30643, tumor response, and overall health using scans and questionnaires. Key measures include dose-limiting toxicities in Phase 1 and objective response rate in Phase 2, tracked over several years. Safety monitoring continues for about 48 months, with various clinical and laboratory tests conducted regularly to understand the drug's effects and patient well-being.
CONDITIONS
Brief 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 (legal adult)
- Diagnosed with locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain
- Received standard therapies for NSCLC
- At least one measurable extracranial tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of 3 months or more
- Adequate blood, liver, and kidney function
You will not qualify if you...
- History of another cancer within the past 2 years
- Known other oncogenic driver alterations or histological transformation
- Unresolved side effects from previous treatments
- Significant uncontrolled medical conditions such as infections
- History of interstitial lung disease
- Significant cardiovascular event within the past 6 months or major organ issues
- Currently receiving other investigational therapies in another clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years
Participants take BH-30643 orally twice daily at doses determined by their assigned dose level. This includes dose escalation and expansion phases to find the recommended dose, followed by Phase 2 treatment at that dose.
Regular visits during dosing as determined by study schedule
Duration - Up to approximately 4 years
Participants are monitored for safety and treatment outcomes after stopping BH-30643, including assessments of survival and disease progression.
Visits as scheduled for safety and outcome monitoring
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
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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