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NCT06706076 · ClinicalTrials.gov registry record · Phase 1
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
A Phase 1 study of NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by BlossomHill Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 266
- Enrollment target
- 20
- Study locations
NCT06706076 is a Phase 1 study of NSCLC (Advanced Non-small Cell Lung Cancer) that is actively recruiting participants, run by BlossomHill Therapeutics. The registered enrollment target is 266 participants, above the 240-participant average among 3 other NSCLC (Advanced Non-small Cell Lung Cancer) trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT06706076, a Phase 1 study of NSCLC (Advanced Non-small Cell Lung Cancer), is actively recruiting participants, sponsored by BlossomHill Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 266 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2025-01-09 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 240-participant average among 3 other NSCLC (Advanced Non-small Cell Lung Cancer) trials with a reported enrollment target (11% higher). The listed sponsor is BlossomHill Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT06706076 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Massachusetts.
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).
What interventions are being tested in trial NCT06706076?
The interventions under investigation include: BH-30643 (DRUG).
Who is sponsoring clinical trial NCT06706076?
This trial is sponsored by BlossomHill Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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