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

NCT06706076 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BH-30643-01
• Study Type: interventional
• Target: 266
• Locations: 9 countries
• Sites: 41

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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)

  Assess dose-limiting toxicities (DLTs) as defined in the study protocol.

  Within the first 21 days of the first dose of BH-30643.

• Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)

  Determine the RP2D for Phase 2.

  Within 21 days of last participant dosed during Dose Expansion/Optimization.

• Objective Response Rate (ORR) (Phase 2)

  Determine ORR as assessed by Blinded Independent Central Review (BICR).

  Approximately 3 years after the first participant dosed.

Secondary Outcomes (14)

• Safety

  From enrollment through study completion, approximately 48 months.

• Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643 for Single dose (Phase 1).

  Predose and up to 24 hours postdose.

• Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).

  Predose and up to 24 hours postdose.

• Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).

  Predose and up to 24 hours postdose.

• Area under the plasma concentration-time curve at steady state (AUCss) of BH-30643 for multiple doses (Phase 1) at steady state.

  Predose and up to 24 hours postdose.

Study Arms (2)

Phase 1 Dose Escalation and Expansion

EXPERIMENTAL

* 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

Drug: BH-30643

Phase 2

EXPERIMENTAL

BH-30643 administered at the RP2D dose determined in Phase 1

Drug: BH-30643

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.

Phase 1 Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify 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.

Sponsors & Collaborators

• BlossomHill Therapeutics: lead

Study Sites (41)

Mayo Clinic Hospital - Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

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

Irvine, California, 92697, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

Yale University - Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Georgetown University Medical Center

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

RECRUITING

Mayo Clinic - Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Sarah Cancer Research Institution - Florida Cancer Specialist

Orlando, Florida, 32827, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Chicago, Illinois, 60611, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Clinic Hospital - Rochester, MN

Rochester, Minnesota, 55905, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Cross Cancer Insitute

Edmonton, Alberta, T6G1Z2, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 227-8577, Japan

RECRUITING

Kindai University Hospital

Osakasayama-shi, Osaka, Japan

RECRUITING

National Cancer Center Hospital

Tsukiji, Tokyo, Japan

RECRUITING

Sarawak General Hosital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

National University Hospital

Kent Ridge, 119074, Singapore

RECRUITING

National Cancer Centre - Singapore

Singapore, 168583, Singapore

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351', South Korea

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Sponsor Contact

CONTACT

(858) 732-3880; clinicaltrials@bhtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-11

Locations

KR (3); JP (3); TW (3); AU (2); MY (1); HK (2); CA (2); US (23); SG (2)