OncRef

Clinical Trial: NCT06685718

A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

Status:

TERMINATED

Phase:

Phase 1

Lead Sponsor:BeOne Medicines
Information Provided By:BeOne Medicines
Last Update Posted:2026-05-22

Study Overview

Brief Summary

This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC.

The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.

Official Title

Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

Conditions

Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma), EGFR Activating Mutation, EGFR Mutation-Related Tumors

Intervention / Treatment

  • Drug: BG-60366

Other Study ID Numbers

  • BG-60366-101
  • 2024-517322-26-00
  • CTR20250272

Start Date (Actual)

2024-12-05

Primary Completion Date (Actual)

2026-04-21

Study Completion Date (Actual)

2026-04-21

Enrollment (Actual)

33

Study Type

Interventional

Phase

Phase 1