Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT06706076 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG BH-30643

Study Locations (20)

California

  • The Regents of the University of California - Irvine, CA Campus — Irvine
  • UC San Diego Moores Cancer Center — La Jolla
  • University of California, Davis Comprehensive Cancer Center — Sacramento
  • Stanford University Medical Center — Stanford

Florida

  • Mayo Clinic - Florida — Jacksonville
  • Sarah Cancer Research Institution - Florida Cancer Specialist — Lake Mary
  • Moffitt Cancer Center — Tampa

Massachusetts

  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • Dana-Farber Cancer Institute — Boston

Arizona

  • Mayo Clinic Hospital - Arizona — Phoenix

Connecticut

  • Yale University - Cancer Center — New Haven

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Illinois

  • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion — Chicago

Michigan

  • Henry Ford Health — Detroit

Trial Details

FieldValue
Enrollment Target 266 participants
Start Date 2025-01-09
Est. Completion 2029-07-31
Phase Phase 1

Sponsor

BlossomHill Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06706076

The ClinicalTrials.gov registry entry for NCT06706076 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BlossomHill Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with NSCLC (Advanced Non-small Cell Lung Cancer) appearing as the primary indexed condition, and to 1 intervention — of which BH-30643 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06706076 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06706076 about?

NCT06706076 is a clinical study titled "A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations". 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 app...

What is the current status of trial NCT06706076?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 266 participants. The study started on 2025-01-09. Estimated completion is 2029-07-31.

What conditions does trial NCT06706076 study?

This clinical trial studies the following conditions: NSCLC (Advanced Non-small Cell Lung Cancer). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06706076?

The interventions under investigation include: BH-30643 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06706076?

This trial is sponsored by BlossomHill Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06706076 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial