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Clinical Trials in China / NCT06120283
Recruiting Phase 1

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

NCT06120283 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2023-12-01
Last updated
2026-09-11

Condition(s) studied

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 Cancer

Investigational drug(s) / intervention(s)

BGB-43395 →Fulvestrant →Letrozole →Elacestrant →Anti-Diarrheal Agent

BGB-43395: Planned doses administered orally.

Fulvestrant: Standard dose administered via intramuscular injection.

Letrozole: Standard dose administered orally as a tablet.

Elacestrant: Standard dose administered orally as a tablet.

Anti-Diarrheal Agent: Administered orally as a tablet.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
Sarah Cannon Research Institute (Scri) At Health One Denver Colorado Recruiting
Florida Cancer Specialists and Research Institute Lake Mary Florida Completed
Karmanos Cancer Institute Detroit Michigan Completed
Washington University School of Medicine St Louis Missouri Recruiting
Duke Cancer Center Durham North Carolina Recruiting
James Cancer Hospital and Solove Research Institute Columbus Ohio Recruiting
Scri Oncology Partners Nashville Tennessee Recruiting
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Next Oncology Dallas Irving Texas Recruiting
Next Oncology San Antonio Texas Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Southern Highlands Private Hospital Bowral New South Wales Recruiting
Concord Repatriation General Hospital Concord New South Wales Recruiting
Macquarie University North Ryde New South Wales Recruiting
Townsville University Hospital Douglas Queensland Recruiting
Genesiscare St Andrews Adelaide South Australia Recruiting
Austin Health Heidelberg Victoria Completed
Peter Maccallum Cancer Centre Melbourne Victoria Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos Barretos Brazil Recruiting
Hospital Sirio Libanes Brasilia Brasília Brazil Recruiting
Centro de Pesquisas Oncologicas Cepon Florianópolis Brazil Recruiting
Liga Norte Riograndene Contra O Cancer Natal Brazil Recruiting
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude Petrópolis Brazil Recruiting
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia Porto Algre Brazil Recruiting
Instituto Nacional de Cancer Rio de Janeiro Brazil Recruiting
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael Salvador Brazil Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira São Paulo Brazil Recruiting
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria São Paulo Brazil Recruiting
Hospital Israelita Albert Einstein São Paulo Brazil Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) Guangzhou Guangdong Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Nanchang University Branch Donghu Nanchang Jiangxi Recruiting
Liaoning Cancer Hospital and Institute Shenyang Liaoning Recruiting
Fudan University Shanghai Cancer Centerpudong Shanghai Shanghai Municipality Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie Bordeaux France Recruiting
Centre Francois Baclesse Caen France Recruiting
Centre Oscar Lambret Lille France Recruiting
Institut Paoli Calmettes Marseille France Recruiting

+ 22 more sites — see the full list on the official registry below.

More BeOne Medicines trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06120283 on ClinicalTrials.gov ↗ ← All trials in China