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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: Recruiting Phase 1 study of NSCLC (Advanced Non-small Cell Lung Cancer), sponsored by BlossomHill Therapeutics.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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

Conditions Studied

NSCLC (Advanced Non-small Cell Lung Cancer)

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
BlossomHill Therapeutics

2 total trials

What NCT06706076 shows while recruiting

NCT06706076 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 240-participant average among 3 other NSCLC (Advanced Non-small Cell Lung Cancer) trials with a reported enrollment target (11% higher).

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 names 20 study sites across 13 states, led by 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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More recruiting context for NCT06706076

Source: ClinicalTrials.gov NCT06706076, the US trial registry maintained by the National Library of Medicine. NCT06706076 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.