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

NCT06706076 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-04-24

No results posted yet for this 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

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • BlossomHill Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2029-01-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hong Kong
  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706076 on ClinicalTrials.gov