BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

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

Phase

1

Condition

Breast Cancer

Non-small Cell Lung Cancer

Metastatic Cancer

Treatment

Letrozole

BGB-43395

Fulvestrant

Clinical Study ID

NCT06120283
BGB-43395-101
2023-506888-34-00
CTR20243370
  • Ages > 18
  • All Genders

Study Summary

This is a dose escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologicallyor cytologically confirmed advanced, metastatic, or unresectable solid tumorsassociated with dependency on CDK4, including HR+ breast cancer, ovarian cancer,endometrial cancer, non-small cell lung cancer, and others.

  • Phase 1a: Received prior therapy for their condition (if available) and should berefractory to or intolerant of standard-of-care therapies. In regions where approvedand available, participants with HR+ breast cancer must have received at least 2prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.

  • Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additionaltumor types.

  • Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6inhibitors are approved and available must have received at least one line oftherapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor.Participants can have received up to 2 lines of prior cytotoxic chemotherapy foradvanced disease.

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

  • Female participants with metastatic HR+/HER2- breast cancer must be postmenopausalor receiving ovarian function suppression treatment.

  • Adequate organ function without symptomatic visceral disease.

Exclusion

Exclusion Criteria:

  • Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy ispermitted and required in local regions where it is approved and available).

  • Known leptomeningeal disease or uncontrolled, untreated brain metastases.

  • Any malignancy ≤ 3 years before the first dose of study treatment(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

  • Uncontrolled diabetes.

  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28days before the first dose of study drug(s), or symptomatic COVID-19 infection.

  • History of hepatitis B or active hepatitis C infection.

  • Prior allogeneic stem cell transplantation, or organ transplantation.

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

Study Design

Total Participants: 79
Treatment Group(s): 3
Primary Treatment: Letrozole
Phase: 1
Study Start date:
December 01, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Southern Highlands Private Hospital

    Bowral, New South Wales 2576
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Active - Recruiting

  • Townsville University Hospital

    Douglas, Queensland 4814
    Australia

    Active - Recruiting

  • Genesiscare St Andrews

    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

    Active - Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasilia, 70200-730
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Oncologicas Cepon

    Florianopolis, 88034-000
    Brazil

    Active - Recruiting

  • Liga Norte Riograndene Contra O Cancer

    Natal, 59062-000
    Brazil

    Active - Recruiting

  • Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

    Petropolis, 95070-560
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia

    Porto Algre, 90610-000
    Brazil

    Active - Recruiting

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20560-120
    Brazil

    Active - Recruiting

  • Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael

    Salvador, 41253-190
    Brazil

    Active - Recruiting

  • Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

    Sao Paulo, 01317-000
    Brazil

    Active - Recruiting

  • Hospital Israelita Albert Einstein

    Sao Paulo, 05652-900
    Brazil

    Active - Recruiting

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

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    Guangzhou, Guangdong 510245
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Centerpudong

    Shanghai, Shanghai 201321
    China

    Active - Recruiting

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Francois Baclesse

    Caen Cedex, 14076
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59000
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35043
    France

    Active - Recruiting

  • Institut de Cancerologie de Louest

    St Herblain, 44800
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Nagoya University Hospital

    Nagoya, Aichi 466-8560
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Suntogun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnamsi, Gyeonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, Gyeonggi-do 02841
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, Incheon Gwang'yeogsi 21565
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Pulau Pinang Hospital

    Georgetown, 10450
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • National Cancer Institute (Institut Kanser Negara)

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025
    Moldova, Republic of

    Active - Recruiting

  • Harbour Cancer and Wellness

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Nzcr Christchurch

    Christchurch, 8011
    New Zealand

    Active - Recruiting

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Site Not Available

  • Banphaeo General Hospital

    Banphaeo, 74120
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002
    Thailand

    Active - Recruiting

  • Sarah Cannon Research Institute (Scri) At Health One

    Denver, Colorado 80219
    United States

    Active - Recruiting

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Scri Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • Next Dallas

    Irving, Texas 75039
    United States

    Active - Recruiting

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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