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

NCT06685718 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: BG-60366-1012024-517322-26-00CTR20250272
• Study Type: interventional
• Target: 33
• Locations: 7 countries
• Sites: 29

Brief 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.

Conditions

Lung Cancer; NSCLC; EGFR Activating Mutation; Non-Small Cell Lung Cancer; NSCLC (Non-small Cell Lung Carcinoma); EGFR Mutation-Related Tumors

Keywords

lung cancer; non-small cell lung cancer; NSCLC; EGFR activating mutation; EGFR resistant mutation; advanced or metastatic non-small cell lung cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• Phase 1a: Overall Response Rate (ORR)

  Approximately 24 months

• Phase 1a and 1b: Duration of Response (DOR)

  Approximately 24 months

• Phase 1a and 1b: Time to Response (TTR)

  Approximately 24 months

• Phase 1b: Progression-Free Survival (PFS)

  Approximately 24 months

• Phase 1b: Disease Control Rate (DCR)

  Approximately 24 months

Study Arms (2)

Phase 1a: Dose Escalation and Safety Expansion

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.

Drug: BG-60366

Phase 1b: Dose Expansion

EXPERIMENTAL

Recommended Dose(s) for Expansion (RDFE\[s\]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.

Drug: BG-60366

Interventions

BG-60366 DRUG

Administered orally

Phase 1a: Dose Escalation and Safety Expansion; Phase 1b: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (29)

University of Colorado

Denver, Colorado, 80202-1702, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5418, United States

Location

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, 63110-1032, United States

Location

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, 10065-6800, United States

Location

Ohio State University

Columbus, Ohio, 43210-1132, United States

Location

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, NSW 2170, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, QLD 4102, Australia

Location

Cancer Research South Australia

Adelaide, South Australia, SA 5000, Australia

Location

Austin Health

Heidelberg, Victoria, VIC 3084, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Guangdong Provincial Peoples Hospital Huifu Branch

Guangzhou, Guangdong, 510120, China

Location

The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

Nanning, Guangxi, 530201, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

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

Hangzhou, Zhejiang, 310018, China

Location

Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia

Monza, 20900, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Harbour Cancer and Wellness

Auckland, 1023, New Zealand

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, 28644, South Korea

Location

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Hospital Universitario Vall Dhebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

H Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

ES (3); AU (6); IT (2); CN (7); KR (4); NZ (1); US (6)