drugset
drugset / Trial / NCT06706076

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

NCT06706076 ↗

Phase 1/2 Recruiting 266 enrolled BlossomHill Therapeutics
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-09
Primary completion
2029-01-31
Completion
2029-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BH-30643 Unknown 10 mg Oral
Subject BH-30643 Unknown 40 mg Oral

Indications

non-small cell lung carcinoma