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NCT06706076 | RECRUITING | NSCLC (Advanced Non-small Cell Lung Cancer)

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

BlossomHill Therapeutics

Brief 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.

Condition or disease

NSCLC (Advanced Non-small Cell Lung Cancer)

Intervention/treatment

BH-30643

BH-30643

Phase

PHASE1

PHASE2

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 266 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-01-09
Estimated Primary Completion Date : 2029-01-31
Estimated Study Completion Date : 2029-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * ≥ 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.
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.
  • * 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.
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

Location Details

NCT06706076

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

The Regents of the University of California - Irvine, CA Campus

Irvine, California, United States, 92697

RECRUITING

United States, California

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

RECRUITING

United States, Florida

Sarah Cancer Research Institution - Florida Cancer Specialist

Lake Mary, Florida, United States, 32746

RECRUITING

United States, Illinois

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Chicago, Illinois, United States, 60611

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas - M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

NEXT Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

Japan, Tokyo

National Cancer Center Hospital

Tsukiji, Tokyo, Japan,