A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
NCT ID: NCT06685718
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
93 participants
INTERVENTIONAL
2024-11-26
2028-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1a: Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.
BG-60366
Administered orally
Phase 1b: Dose Expansion
Recommended Dose(s) for Expansion (RDFE\[s\]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.
BG-60366
Administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BG-60366
Administered orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Disease progression on prior third-generation EGFR-TKI for advanced or metastatic disease, and either progressed or ineligible for currently available standard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKI treatment
* Phase 1a safety expansion
* Documentation of EGFR resistance mutations (ie, C797s)
* At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1
* EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment
* Adequate organ function
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion Criteria
* Symptomatic spinal cord compression
* Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug)
* Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs)
* Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening
* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BeiGene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 Policlinico Universitario Agostino Gemelli
Roma, , Italy
Harbour Cancer and Wellness
Auckland, , New Zealand
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-517322-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
BG-60366-101
Identifier Type: -
Identifier Source: org_study_id