RecruitingPhase 1NCT06685718

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

Sponsor

BeiGene

Enrollment

93 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new experimental drug called BG-60366 in adults with a type of lung cancer (non-small cell lung cancer, NSCLC) driven by EGFR gene changes, whose cancer has stopped responding to standard EGFR-targeted therapies. **You may be eligible if...** - You have been diagnosed with NSCLC with an EGFR mutation - Your cancer progressed after treatment with a third-generation EGFR-targeted drug (like osimertinib) - You are physically functional (ECOG performance status 0–1) - Your organ function is in an acceptable range - You have at least one measurable tumor on a scan **You may NOT be eligible if...** - Your lung cancer has small cell features - You have symptomatic spinal cord compression - You have brain metastases that are causing symptoms or need urgent treatment - You have a history of serious lung inflammation (interstitial lung disease) - You have previously been treated with a fourth-generation EGFR drug - You have uncontrolled fluid buildup in the lungs or abdomen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBG-60366

Administered orally

Locations(28)

University of Colorado

Denver, Colorado, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, China

The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

Nanning, Guangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

Hangzhou, Zhejiang, China

Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia

Monza, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Harbour Cancer and Wellness

Auckland, New Zealand

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitario Vall Dhebron

Barcelona, Spain

Hospital Universitario de Octubre

Madrid, Spain

H Puerta de Hierro Majadahonda

Majadahonda, Spain

View Full Details on ClinicalTrials.gov

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NCT06685718