Thinking of joining a study?

Register your interest

Become a volunteer?

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:

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.

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, non-covalent, macrocyclic, mutant selective OMNI-EGFR inhibitor that targets a broad diversity of mutations in the EGFR kinase domain. These include EGFR classical mutations (e.g., ex19del and L858R) as well as less common (atypical) mutations (including G719X, S768I, L861Q, E709X, and beyond). BH-30643 also overcomes a variety of mutations which can cause resistance to previously approved EGFR TKIs (including both C797S and T790M). BH-30643 was designed to be selective over wildtype EGFR and HER2.

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

Please Choose a site

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, Arizona

Mayo Clinic Hospital - Arizona

Phoenix, arizona, United States, 85054

RECRUITING

United States, California

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

Irvine, California, United States, 92697

RECRUITING

United States, California

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

RECRUITING

United States, California

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

RECRUITING

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305

RECRUITING

United States, Connecticut

Yale University - Cancer Center

New Haven, Connecticut, United States, 06520

RECRUITING

United States, District of Columbia

Georgetown University Medical Center

Washington D.C., District of Columbia, United States, 20007

RECRUITING

United States, Florida

Mayo Clinic - Florida

Jacksonville, florida, United States, 32224

RECRUITING

United States, Florida

Sarah Cancer Research Institution - Florida Cancer Specialist

Lake Mary, florida, United States, 32746

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, florida, United States, 33612

RECRUITING

United States, Illinois

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Chicago, Illinois, United States, 60611

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02214

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, road cancer

Henry Ford Health

Detroit, road cancer, United States, 48202

RECRUITING

United States, Minnesota

Mayo Clinic Hospital - Rochester, MN

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States, 19107

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

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

RECRUITING

Australia, Victoria

Austin Health

Heidelberg, Victoria, Australia, 3084

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

RECRUITING

Canada, Alberta

Cross Cancer Insitute

Edmonton, Alberta, Canada, T6G1Z2

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2C4

RECRUITING

Hong Kong, New Territories

Prince of Wales Hospital

The chart, New Territories, Hong Kong,

RECRUITING

Hong Kong,

Queen Mary Hospital

Hong Kong, Hong Kong,

RECRUITING

Japan, Chiba

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 227-8577

RECRUITING

Japan, Osaka

Kindai University Hospital

Upside-down Saya Merci, Osaka, Japan,

RECRUITING

Japan, Tokyo

National Cancer Center Hospital

Tsukiji, Tokyo, Japan,

RECRUITING

Malaysia, Sarawak

Sarawak General Hospital

Kuching, Sarawak, Malaysia, 93586

RECRUITING

Singapore,

National University Hospital

Kent Ridge, Singapore, 119074

RECRUITING

Singapore,

National Cancer Centre - Singapore

Singapore, Singapore, 168583

RECRUITING

South Korea,

Seoul National University Hospital

Seoul, South Korea, 03080

RECRUITING

South Korea,

Samsung Medical Center

Seoul, South Korea, 06351'

RECRUITING

Taiwan,

Taichung Veterans General Hospital

Taichung, Taiwan, 407219

RECRUITING

Taiwan,

National Taiwan University Cancer Center

Taipei, Taiwan,

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan,