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

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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer; NSCLC; Lung Cancer; EGFR Activating Mutation; EGFR Mutation-Related Tumors; NSCLC (Non-small Cell Lung Carcinoma)
• Intervention / Treatment: Drug: BG-60366

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Blacktown Cancer and Haematology Centre
    • Liverpool, New South Wales, Australia, NSW 2170
      • Liverpool Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, QLD 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, SA 5000
      • Cancer Research South Australia
  • Victoria
    • Heidelberg, Victoria, Australia, VIC 3084
      • Austin Health
    • Melbourne, Victoria, Australia, VIC 3000
      • Peter MacCallum Cancer Centre
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial Peoples Hospital Huifu Branch
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310018
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
• Italy
  • Monza, Italy, 20900
    • Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli
• New Zealand
  • Auckland, New Zealand, 1023
    • Harbour Cancer and Wellness
• South Korea
  • Chungcheongbukdo
    • Cheongju-si, Chungcheongbukdo, South Korea, 28644
      • Chungbuk National University Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall dHebron
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Majadahonda, Spain, 28222
    • H Puerta de Hierro Majadahonda
• United States
  • Colorado
    • Denver, Colorado, United States, 80202-1702
      • University of Colorado
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Dana Farber Cancer Institute
  • Missouri
    • St Louis, Missouri, United States, 63110-1032
      • Washington University School of Medicine Siteman Cancer Center
  • New York
    • New York, New York, United States, 10065-6800
      • Memorial Sloan Kettering Cancer Center Mskcc
  • Ohio
    • Columbus, Ohio, United States, 43210-1132
      • Ohio State University
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Dose Escalation and Safety Expansion; Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.	Drug: BG-60366; Administered orally
Experimental: Phase 1b: Dose Expansion; Recommended Dose(s) for Expansion (RDFE[s]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.	Drug: BG-60366; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with AEs and SAEs, including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.	From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)	MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.	Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366	RDFE of BG-60366 will be determined based upon the MTD or MAD.	Approximately 18 months
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events	Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, and laboratory assessments as needed.	From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Overall Response Rate (ORR)	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Overall Response Rate (ORR)	ORR is defined as the percentage of participants who had confirmed CR or PR assessed by the investigator using RECIST v1.1.	Approximately 24 months
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of objective response that is confirmed by the subsequent assessment until the first documentation of disease progression or death, whichever comes first.	Approximately 24 months
Phase 1a and 1b: Time to Response (TTR)	TTR is defined as the time from the date of the first dose of study drugs to the date of teh first determination of objective response that is confirmed by the subsequent assessment.	Approximately 24 months
Phase 1b: Progression-Free Survival (PFS)	PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.	Approximately 24 months
Phase 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease assessed.	Approximately 24 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-60366		Twice in the first 3 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) of BG-60366		Twice in the first 3 months
Phase 1a and 1b: Accumulation Ratio (AR) of BG-60366		Once in the first three months
Phase 1a and 1b: Plasma concentrations of BG-60366		Approximately up to 6 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Actual): April 21, 2026
• Study Completion (Actual): April 21, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; lung cancer; non-small cell lung cancer; EGFR activating mutation; advanced or metastatic non-small cell lung cancer; EGFR resistant mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BG-60366-101; 2024-517322-26-00 (Ctis); CTR20250272 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No