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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBlossomHill Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ 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 โ‰ค 1. * Has a life expectancy of โ‰ฅ 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.
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What it tests

  • BH-30643
  • BH-30643 combo therapy with Carboplatin/Pemetrexed
  • BH-30643
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Where

42 sites
Mayo Clinic Hospital - Arizona
Phoenix, United States
The Regents of the University of California - Irvine, CA Campus
Irvine, United States
UC San Diego Moores Cancer Center
La Jolla, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, United States
Stanford University Medical Center
Stanford, United States
Yale University - Cancer Center
New Haven, United States
Georgetown University Medical Center
Washington D.C., United States
Mayo Clinic - Florida
Jacksonville, United States

โ€ฆand 34 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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