RecruitingPhase 1NCT06120283

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

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

Sponsor

BeOne Medicines

Enrollment

399 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast Cancer Advanced Solid Tumor Advanced Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BGB-43395, alone or in combination with other treatments, for people with advanced cancers including hormone receptor-positive (HR+) breast cancer and other solid tumors that depend on a protein called CDK4 to grow. **You may be eligible if...** - You have advanced, metastatic, or inoperable solid tumors that may depend on CDK4 (including HR+/HER2- breast cancer, ovarian, endometrial, or lung cancer) - You have received prior standard treatments including hormonal therapy and a CDK4/6 inhibitor (for HR+ breast cancer) - You are in good overall health (ECOG 0 or 1) with adequate organ function **You may NOT be eligible if...** - You have previously received a therapy that specifically targets CDK4 alone (note: prior CDK4/6 inhibitors are allowed) - You have uncontrolled brain metastases or cancer spread to the lining around the brain - You have had another cancer diagnosis within the last 3 years - You have uncontrolled diabetes or an active serious infection - You have untreated or active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-43395

Planned doses administered orally.

DRUGFulvestrant

Standard dose administered via intramuscular injection.

DRUGLetrozole

Standard dose administered orally as a tablet.

DRUGElacestrant

Standard dose administered orally as a tablet.

DRUGAnti-Diarrheal Agent

Administered orally as a tablet.

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

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