Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT06685718

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

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

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
33 (actual)
Sponsor
BeOne Medicines · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Conditions

Interventions

TypeNameDescription
DRUGBG-60366Administered orally

Timeline

Start date
2024-12-05
Primary completion
2026-05-15
Completion
2026-05-15
First posted
2024-11-12
Last updated
2026-04-15

Locations

29 sites across 7 countries: United States, Australia, China, Italy, New Zealand, South Korea, Spain

Regulatory

Source: ClinicalTrials.gov record NCT06685718. Inclusion in this directory is not an endorsement.