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RECRUITING

NCT06120283

PHASE1

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

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant 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.

Official title: A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-12-01

Completion Date

2028-06

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer Hormone-receptor-positive Breast Cancer Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Malignant Neoplasm of Breast HER2-negative Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer Non-small Cell Lung Cancer

Interventions

DRUG

BGB-43395

Planned doses administered orally.

DRUG

Fulvestrant

Standard dose administered via intramuscular injection.

DRUG

Letrozole

Standard dose administered orally as a tablet.

DRUG

Elacestrant

Standard dose administered orally as a tablet.

Inclusion Criteria: * Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated 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 be refractory to, or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. * Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types. * Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. * Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment. * Adequate organ function without symptomatic visceral disease. Exclusion Criteria: * Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted 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 the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). * Uncontrolled diabetes. * Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection. * Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening. * Participants with active hepatitis C infection. * Prior allogeneic stem cell transplantation, or organ transplantation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (63)

Sarah Cannon Research Institute (Scri) At Health One

Denver, Colorado, United States

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Duke Cancer Center

Durham, North Carolina, United States

James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

Scri Oncology Partners

Nashville, Tennessee, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Next Dallas

Irving, Texas, United States

Next Oncology

San Antonio, Texas, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Southern Highlands Private Hospital

Bowral, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Townsville University Hospital

Douglas, Queensland, Australia

Genesiscare St Andrews

Adelaide, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, Brazil

Hospital Sirio Libanes Brasilia

Brasília, Brazil

Centro de Pesquisas Oncologicas Cepon

Florianópolis, Brazil

Liga Norte Riograndene Contra O Cancer

Natal, Brazil

Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

Petrópolis, Brazil

Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia

Porto Algre, Brazil

Instituto Nacional de Cancer

Rio de Janeiro, Brazil

Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael

Salvador, Brazil

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

São Paulo, Brazil

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

São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, Brazil

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

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

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, China

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

Institut Paoli Calmettes

Marseille, France

Institut Curie

Paris, France

Centre Eugene Marquis

Rennes, France

Institut de Cancerologie de Louest

Saint-Herblain, France

Institut Gustave Roussy

Villejuif, France

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shizuoka Cancer Center

Suntogun, Shizuoka, Japan

Pulau Pinang Hospital

George Town, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, Malaysia

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova

Harbour Cancer and Wellness

Auckland, New Zealand

Nzcr Christchurch

Christchurch, New Zealand

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Korea University Anam Hospital

SeongbukGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Srinagarind Hospital (Khon Kaen University)

Muang, Thailand

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)