A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
NCT06685718 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2026-05-22
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.
Conditions
- Non-Small Cell Lung Cancer
- Lung Cancer
- NSCLC
- NSCLC (Non-small Cell Lung Carcinoma)
- EGFR Activating Mutation
- EGFR Mutation-Related Tumors
Interventions
- DRUG
-
BG-60366
Administered orally
Sponsors & Collaborators
-
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-05
- Primary Completion
- 2026-04-21
- Completion
- 2026-04-21
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- Italy
- New Zealand
- South Korea
- Spain
Study Locations
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