Recruiting
Phase 1
Phase 2

BH-30643

Sponsor:

BlossomHill Therapeutics

Code:

NCT06706076

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BH-30643

BH-30643 combo therapy with Carboplatin/Pemetrexed

BH-30643

Study Details

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, both as a monotherapy and in combination with chemotherapy.

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)

Study ID

NCT06706076

Start date

Jan 9, 2025

Status verified date

Nov, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 18 years or legal adult.
  • Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.
  • 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.
  • Active or history of interstitial lung disease from any cause
  • Clinically significant cardiovascular event within 6 months or significant history of major organ.

  • The above are a summary; other Exclusion Criteria details may apply.

Study Design

Enrollment

675 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 Monotherapy Dose Escalation and Expansion

  • BH-30643 monotherapy for dose escalation
  • BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data

experimental: Phase 1 Combination Dose Escalation and Expansion

  • BH-30643 combo therapy with Carboplatin/Pemetrexed for dose escalation
  • BH-30643 combo therapy with Carboplatin/Pemetrexed for dose expansion /optimization at doses determined from dose escalation data

experimental: Phase 2

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

Interventions

BH-30643

BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets. Subjects will take BH-30643 orally depending on their dose level assignment.

BH-30643 combo therapy with Carboplatin/Pemetrexed

BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets in combo therapy with Carboplatin/Pemetrexed. Subjects will take BH-30643 orally depending on their dose level assignment. Carboplatin/Pemetrexed will be administered according to standard of care

BH-30643

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

Primary outcome measure

  • Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) [ Time Frame: Within the first 21 days of the first dose of BH-30643. ]
  • Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization) [ Time Frame: Within 21 days of last participant dosed during Dose Expansion/Optimization. ]
  • Objective Response Rate (ORR) (Phase 2) [ Time Frame: Approximately 3 years after the first participant dosed. ]

Central Contacts and Locations

Central contacts

Sponsor Contact

(858) 732-3880clinicaltrials@bhtherapeutics.com

Locations

Mayo Clinic Hospital - Arizona

Recruiting

Phoenix, Arizona, United States, 85054

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

Recruiting

Irvine, California, United States, 92697

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

University of California, Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Yale University - Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Georgetown University Medical Center

Recruiting

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

Mayo Clinic - Florida

Recruiting

Jacksonville, Florida, United States, 32224

Sarah Cancer Research Institution - Florida Cancer Specialist

Recruiting

Orlando, Florida, United States, 32827

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion

Recruiting

Chicago, Illinois, United States, 60611

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02214

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Mayo Clinic Hospital - Rochester, MN

Recruiting

Rochester, Minnesota, United States, 55905

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Thomas Jefferson University, Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Sarah Cannon Research Institute, LLC

Recruiting

Nashville, Tennessee, United States, 37203

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

Recruiting

Houston, Texas, United States, 77030

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G1Z2

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

BlossomHill Therapeutics

Last update posted

Aug 5, 2026

Last verified

Nov, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BlossomHill Therapeutics on 2026-08-05.