RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06120283

Registry updated: 2026-10-15

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Description

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.

Interventions

BGB-43395 (Drug)
Planned doses administered orally.
Fulvestrant (Drug)
Standard dose administered via intramuscular injection.
Letrozole (Drug)
Standard dose administered orally as a tablet.
Elacestrant (Drug)
Standard dose administered orally as a tablet.
Anti-Diarrheal Agent (Drug)
Administered orally as a tablet.

Eligibility criteria

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. 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.

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

Locations

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
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 Oncology 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
Fundacao Universidade de Caxias Do Sul — Caxias do Sul, Brazil
Centro de Pesquisas Oncologicas Cepon — Florianópolis, Brazil
Liga Norte Riograndene Contra O Cancer — Natal, 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
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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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