A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Recruiting · NCT06706076 · Interventional (participants receive a specific treatment) · Lead sponsor: BlossomHill Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
BH-30643BH-30643 combo therapy with Carboplatin/Pemetrexed
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, both as a monotherapy and in combination with chemotherapy. 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥ 18 years or legal adult.
- Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
- 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.
- Active or history of interstitial lung disease from any cause
- Clinically significant cardiovascular event within 6 months or significant history of major organ.
- The above are a summary; other Exclusion Criteria details may apply.
Where it is running
42 locations listed across 16 US states.
- Mayo Clinic Hospital - Arizona - Phoenix, Arizona, United States
- The Regents of the University of California - Irvine, CA Campus - Irvine, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- University of California, Davis Comprehensive Cancer Center - Sacramento, California, United States
- Stanford University Medical Center - Stanford, California, United States
- Yale University - Cancer Center - New Haven, Connecticut, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- Mayo Clinic - Florida - Jacksonville, Florida, United States
- Sarah Cancer Research Institution - Florida Cancer Specialist - Orlando, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion - Chicago, Illinois, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Henry Ford Health - Detroit, Michigan, United States
- Mayo Clinic Hospital - Rochester, MN - Rochester, Minnesota, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Duke Cancer Institute - Durham, North Carolina, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute, LLC - Nashville, Tennessee, United States
- The University of Texas - M.D. Anderson Cancer Center - Houston, Texas, United States
- NEXT Virginia - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Queen Mary Hospital - Hong Kong, Hong Kong
- National University Hospital - Kent Ridge, Singapore
- Seoul National University Hospital - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- National Cancer Centre - Singapore - Singapore, Singapore
- Taichung Veterans General Hospital - Taichung, Taiwan
- National Taiwan University Cancer Center - Taipei, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Cross Cancer Institute - Edmonton, Alberta, Canada
- National Cancer Center Hospital East - Kashiwa, Chiba, Japan
- Prince of Wales Hospital - Shatin, New Territories, Hong Kong
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Kindai University Hospital - Osakasayama-shi, Osaka, Japan
- Sarawak General Hospital - Kuching, Sarawak, Malaysia
- National Cancer Center Hospital - Tsukiji, Tokyo, Japan
- Austin Health - Heidelberg, Victoria, Australia
- Peter MacCallum Cancer Centre - Melbourne, Victoria, Australia