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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BlossomHill Therapeutics
Study ID
NCT06706076
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BH-30643 — DRUG
    BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.
  • BH-30643 — DRUG
    BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment.

Study Details

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. 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 Dates

Start date
Jan 9, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
266 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation and Expansion
    * BH-30643 monotherapy for dose escalation * BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data * BH-30643 twice daily oral dosing
  • Experimental: Phase 2
    BH-30643 administered at the RP2D dose determined in Phase 1

Primary Outcome Measure

Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) [ Time Frame: Within the first 21 days of the first dose of BH-30643. ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital - ArizonaPhoenixArizona85054-
The Regents of the University of California - Irvine, CA CampusIrvineCalifornia92697-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Stanford University Medical CenterStanfordCalifornia94305-
Yale University - Cancer CenterNew HavenConnecticut06520-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Mayo Clinic - FloridaJacksonvilleFlorida32224-
Sarah Cancer Research Institution - Florida Cancer SpecialistOrlandoFlorida32827-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionChicagoIllinois60611-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Henry Ford HealthDetroitMichigan48202-
Mayo Clinic Hospital - Rochester, MNRochesterMinnesota55905-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Sarah Cannon Research Institute, LLCNashvilleTennessee37203-
The University of Texas - M.D. Anderson Cancer CenterHoustonTexas77030-
NEXT VirginiaFairfaxVirginia22031-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital - Arizona· Phoenix, AZThe Regents of the University of California - Irvine, CA Campus· Irvine, CAUC San Diego Moores Cancer Center· La Jolla, CAUniversity of California, Davis Comprehensive Cancer Center· Sacramento, CAStanford University Medical Center· Stanford, CAYale University - Cancer Center· New Haven, CT

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