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

Stopped early · Phase 1

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

In brief

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.

Key facts

Study ID

NCT06685718

Run by

BeOne Medicines

People needed

33

Starts

2024-12-05

Expected to finish

2026-04-21

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
• Phase 1a general 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

You may not qualify if…

• Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment
• 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
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• 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
• Chungbuk National University Hospital — Cheongju-si, Chungcheongbukdo, South Korea
• Samsung Medical Center — GangnamGu, Seoul Teugbyeolsi, South Korea
• Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.