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

NCT06706076

RecruitingPhase 1, Phase 2

Sponsor: BlossomHill Therapeutics

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

Interventions: BH-30643, BH-30643 combo therapy with Carboplatin/Pemetrexed, BH-30643

Countries: United States, Australia, Canada, Hong Kong, Japan, Malaysia, Singapore, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (42)
  • Phoenix, Arizona, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Sacramento, California, United States
  • Stanford, California, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Seattle, Washington, United States
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Edmonton, Alberta, Canada
  • Toronto, Ontario, Canada
  • Shatin, New Territories, Hong Kong
  • Hong Kong, Hong Kong
  • + 12 more on CT.gov