RECRUITING

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

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Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)NSCLCLocally Advanced NSCLCMetastatic NSCLCNon-small Cell Lung CancerHER2 mutationEGFR mutationEGFR classical mutationEGFR atypical mutationEGFR exon20 insertionEGFR uncommon mutationEGFR resistant mutationBH-30643Tyrosine kinase inhibitorTKIEGFROMNI-EGFREGFR kinase domain mutationsEGFR common mutationEGFR activating mutationEx19delEGFR del E746_A750Exon 19 deletionL858RC797SC797GC797XT790MG719XG724XL718VL718XL861QS768IS768XE709XL747XExon 19 insertionL833XL861XV769XV834X

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-01-09
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06706076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years or legal adult.
  2. * 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.
  3. * Had received standard therapies.
  4. * Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
  5. * Eastern Cooperative Oncology Group Performance Status ≤ 1.
  6. * Has a life expectancy of ≥ 3 months.
  7. * Has adequate hematologic, hepatic, and renal function. \*The above are a summary; other Inclusion Criteria details may apply.
  1. * History of any concurrent malignancy within the previous 2 years.
  2. * Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
  3. * Unresolved toxicities from prior therapies.
  4. * Any significant and uncontrolled medical condition, such as infection.
  5. * History of interstitial lung disease from any cause
  6. * Clinically significant cardiovascular event within 6 months or significant history of major organ.
  7. * Actively receiving investigational therapy(ies) in another clinical study. \*The above are a summary; other Exclusion Criteria details may apply.

Contacts and Locations

Study Contact

Sponsor Contact
CONTACT
(858) 732-3880
clinicaltrials@bhtherapeutics.com

Study Locations (Sites)

Mayo Clinic Hospital - Arizona
Phoenix, Arizona, 85054
United States
The Regents of the University of California - Irvine, CA Campus
Irvine, California, 92697
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224
United States
Sarah Cancer Research Institution - Florida Cancer Specialist
Lake Mary, Florida, 32746
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, 60611
United States
Massachusetts General Hospital
Boston, Massachusetts, 02214
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Mayo Clinic Hospital - Rochester, MN
Rochester, Minnesota, 55905
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
United States
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
United States
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: BlossomHill Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

  • 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
  • BH-30643
  • Tyrosine kinase inhibitor
  • TKI
  • EGFR
  • OMNI-EGFR
  • EGFR kinase domain mutations
  • EGFR common mutation
  • EGFR activating mutation
  • Ex19del
  • EGFR del E746_A750
  • Exon 19 deletion
  • L858R
  • C797S
  • C797G
  • C797X
  • T790M
  • G719X
  • G724X
  • L718V
  • L718X
  • L861Q
  • S768I
  • S768X
  • E709X
  • L747X
  • Exon 19 insertion
  • L833X
  • L861X
  • V769X
  • V834X

Additional Relevant MeSH Terms

  • NSCLC (Advanced Non-small Cell Lung Cancer)