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

Last updated: May 7, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

BG-60366

Clinical Study ID

NCT06685718
BG-60366-101
2024-517322-26-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFRactivating 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 ormetastatic disease, and either progressed or ineligible for currently availablestandard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKItreatment

  • Phase 1a safety expansion

  • Documentation of EGFR resistance mutations (ie, C797s)

  • At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) perRECIST v1.1

  • EGFR resistance mutations may be detected locally either from tumor tissue orcirculating tumor DNA (ctDNA) in blood, and samples used for detection of resistancemutations must be collected after progression on the most recent systemic antitumortreatment

  • Adequate organ function

  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion

Exclusion Criteria:

  • Any previous histologic or cytologic evidence of small cell or combined smallcell/non-small cell disease in the archival tumor tissue or tumor biopsy beforeenrollment

  • 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 weeksbefore first dose of study drug)

  • Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targetingchimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with themechanism 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 noninfectiouspneumonitis ≤ 2 years before the first dose of study drug, or has currentILD/noninfectious pneumonitis, or where suspected active ILD/noninfectiouspneumonitis cannot be ruled out by imaging during screening

  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequentdrainage

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 93
Treatment Group(s): 1
Primary Treatment: BG-60366
Phase: 1
Study Start date:
November 26, 2024
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Cancer Research South Australia

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Fundacao Pio Xii Hospital de Amor de Barretos

    Barretos, 14.784-400
    Brazil

    Site Not Available

  • Liga Norte Riograndene Contra O Cancer

    Natal, 59062-000
    Brazil

    Site Not Available

  • Hospital Sao Lucas Da Pucrs

    Porto Alegre, 90610-000
    Brazil

    Site Not Available

  • Hospital Sao Rafael (Rede Dor)

    Salvador, 41253-190
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    Sao Paulo, 05652-900
    Brazil

    Site Not Available

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043-260
    Brazil

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

    Nanning, Guangxi 530201
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

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

    Hangzhou, Zhejiang 310018
    China

    Active - Recruiting

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Fondazione Irccs San Gerardo Dei Tintori Sc Oncologia

    Monza, 20900
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Chungbuk National University Hospital

    SeowonGu CheongjuSi, Chungcheongbukdo 28644
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Sarawak General Hospital

    Kuching, 93586
    Malaysia

    Site Not Available

  • Harbour Cancer and Wellness

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Site Not Available

  • H Puerta de Hierro Majadahonda

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • H Puerta de Hierro Majadahonda

    Majadahonda, 28222
    Spain

    Site Not Available

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400
    Thailand

    Site Not Available

  • Vajira Hospital

    Bangkok, 10300
    Thailand

    Site Not Available

  • Ramathibodi Hospital Mahidol University

    Dusit, 10300
    Thailand

    Site Not Available

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002
    Thailand

    Site Not Available

  • University of Colorado

    Denver, Colorado 80202-1702
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136-2107
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215-5418
    United States

    Active - Recruiting

  • Washington University School of Medicine Siteman Cancer Center

    Saint Louis, Missouri 63110-1032
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210-1132
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

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