A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Recruiting now · Phase 1/Phase 2

Conditions studied: NSCLC (Advanced Non-small Cell Lung Cancer)

In brief

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.

Key facts

Study ID

NCT06706076

Run by

BlossomHill Therapeutics

People needed

675

Starts

2025-01-09

Expected to finish

2029-07-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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

• Mayo Clinic Hospital - Arizona — Phoenix, Arizona, United States (enrolling)
• The Regents of the University of California - Irvine, CA Campus — Irvine, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Yale University - Cancer Center — New Haven, Connecticut, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic - Florida — Jacksonville, Florida, United States (enrolling)
• Sarah Cancer Research Institution - Florida Cancer Specialist — Orlando, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion — Chicago, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Mayo Clinic Hospital - Rochester, MN — Rochester, Minnesota, United States (enrolling)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke Cancer Institute — Durham, North Carolina, United States (enrolling)
• Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institute, LLC — Nashville, Tennessee, United States (enrolling)
• The University of Texas - M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Austin Health — Heidelberg, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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