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

a study on Lung Cancer Non-Small Cell Lung Cancer HER2

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.

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.

Official Title

A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)

Details

BH-30643 is a novel, orally available, reversible, mutant selective, macrocyclic OMNI-EGFR inhibitor that targets mutations in the EGFR kinase domain, including EGFR classical, atypical (also called uncommon or nonclassical), and ex20ins mutations, and a variety of EGFR resistant mutations (eg, ex19del/T790M, ex19del/C797S, ex19del/T790M/C797S, L858R/T790M, L858R/C797S, and L858R/T790M/C797S), as well as HER2 mutations including ex20ins mutations. In addition, BH-30643 has demonstrated good selectivity over wildtype EGFR and HER2. 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.

Keywords

NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC, Locally Advanced NSCLC, Metastatic NSCLC, Non-small Cell Lung Cancer, HER2 mutation, EGFR mutation, EGFR classical mutation, EGFR atypical mutation, EGFR exon20 insertion, EGFR uncommon mutation, EGFR resistant mutation, Non-Small-Cell Lung Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥ 18 years or legal adult.
  • Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
  • Had received standard therapies.
  • 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 CAN'T join 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.
  • History of interstitial lung disease from any cause
  • Clinically significant cardiovascular event within 6 months or significant history of major organ.
  • Actively receiving investigational therapy(ies) in another clinical study. *The above are a summary; other Exclusion Criteria details may apply.

Locations

  • The Regents of the University of California - Irvine, CA Campus accepting new patients
    Irvine California 92697 United States
  • The University of Texas - M.D. Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States
  • Sarah Cannon Research Institute, LLC accepting new patients
    Nashville Tennessee 37203 United States
  • NEXT Virginia accepting new patients
    Fairfax Virginia 22031 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BlossomHill Therapeutics
ID
NCT06706076
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 266 study participants
Last Updated