BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to approximately 60 months
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria. - Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 — Up to approximately 60 months
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached. - Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 — Up to approximately 60 months
RDFE of BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant will be determined based upon the MTD or MAD. - Phase 1b: Objective Response Rate (ORR) — Up to approximately 60 months
ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| 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 |
| Fundacao Universidade de Caxias Do Sul | Caxias do Sul | Brazil | Recruiting |
| Centro de Pesquisas Oncologicas Cepon | Florianópolis | Brazil | Recruiting |
| Liga Norte Riograndene Contra O Cancer | Natal | 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 |
| Institut Curie | Paris | France | Recruiting |
+ 21 more sites — see the full list on the official registry below.
More BeOne Medicines trials in the USA
Other trials for the same condition
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 the USA