Back to Trials
NCT06120283PHASE1Recruiting

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

BeOne Medicines

Start Date

12/1/2023

Completion Date

11/1/2028

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Phase 1a (Dose Escalation): 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. 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 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4/6 inhibitor. For combination with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease. * Phase 1b: Participants with HR+/HER2- breast cancer. * Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced/metastatic disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4/6 inhibitor treatment naïve and have not received any previous systemic treatment 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: * 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.

Interventions

DRUG

BGB-43395

DRUG

Fulvestrant

DRUG

Letrozole

DRUG

Elacestrant

DRUG

Anti-Diarrheal Agent

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid TumorAdvanced Breast CancerMetastatic Breast CancerHormone-receptor-positive Breast CancerHormone Receptor Positive Breast CarcinomaHormone Receptor Positive Malignant Neoplasm of BreastHER2-negative Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerNon-small Cell Lung Cancer

Locations

Sarah Cannon Research Institute (Scri) At Health One

Denver, Colorado 80218-1238

United States

Florida Cancer Specialists and Research Institute

Lake Mary, Florida 32746-2115

United States

Karmanos Cancer Institute

Detroit, Michigan 48201-2013

United States

Washington University School of Medicine

St Louis, Missouri 63110-1010

United States

Duke Cancer Center

Durham, North Carolina 27710-2000

United States

James Cancer Hospital and Solove Research Institute

Columbus, Ohio 43210-1240

United States

Scri Oncology Partners

Nashville, Tennessee 37203-1503

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Next Dallas

Irving, Texas 75039-2743

United States

Next Oncology

San Antonio, Texas 78229-6028

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Southern Highlands Private Hospital

Bowral, New South Wales NSW 2576

Australia

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

Macquarie University

North Ryde, New South Wales NSW 2109

Australia

Townsville University Hospital

Douglas, Queensland QLD 4814

Australia

Genesiscare St Andrews

Adelaide, South Australia SA 5000

Australia

Austin Health

Heidelberg, Victoria VIC 3084

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

Fundacao Pio Xii Hospital de Amor de Barretos

Barretos, 14.784-400

Brazil

Hospital Sirio Libanes Brasilia

Brasília, 70200-730

Brazil

Centro de Pesquisas Oncologicas Cepon

Florianópolis, 88034-000

Brazil

Liga Norte Riograndene Contra O Cancer

Natal, 59062-000

Brazil

Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude

Petrópolis, 95070-560

Brazil

Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia

Porto Algre, 90610-000

Brazil

Instituto Nacional de Cancer

Rio de Janeiro, 20560-120

Brazil

Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael

Salvador, 41253-190

Brazil

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

São Paulo, 01246-000

Brazil

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

São Paulo, 01318-001

Brazil

Hospital Israelita Albert Einstein

São Paulo, 05652-900

Brazil

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Fujian Cancer Hospital

Fuzhou, Fujian 350014

China

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

Guangzhou, Guangdong 510245

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi 330006

China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning 110042

China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality 201321

China

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000

France

Centre Francois Baclesse

Caen, 14000

France

Centre Oscar Lambret

Lille, 59000

France

Institut Paoli Calmettes

Marseille, 13009

France

Institut Curie

Paris, 75005

France

Centre Eugene Marquis

Rennes, 35043

France

Institut de Cancerologie de Louest

Saint-Herblain, 44800

France

Institut Gustave Roussy

Villejuif, 94800

France

Nagoya University Hospital

Nagoya, Aichi-ken 466-8560

Japan

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Shizuoka Cancer Center

Suntogun, Shizuoka 411-8777

Japan

Pulau Pinang Hospital

George Town, 10450

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, 62250

Malaysia

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, 2025

Moldova

Harbour Cancer and Wellness

Auckland, 1023

New Zealand

Nzcr Christchurch

Christchurch, 8011

New Zealand

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi 21565

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Korea University Anam Hospital

SeongbukGu, Seoul Teugbyeolsi 02841

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea

Srinagarind Hospital (Khon Kaen University)

Muang, 40002

Thailand