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

Recruiting now · Phase 1

Conditions studied: 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, Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06120283

Run by

BeOne Medicines

People needed

399

Starts

2023-12-01

Expected to finish

2028-11-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael — Salvador, Brazil (enrolling)
• Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira — São Paulo, Brazil (enrolling)
• Sarah Cannon Research Institute (Scri) At Health One — Denver, Colorado, United States (enrolling)
• Duke Cancer Center — Durham, North Carolina, United States (enrolling)
• James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (enrolling)
• Scri Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Next Dallas — Irving, Texas, United States (enrolling)
• Next Oncology — San Antonio, Texas, United States (enrolling)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
• Southern Highlands Private Hospital — Bowral, New South Wales, Australia (enrolling)
• Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
• Macquarie University — North Ryde, New South Wales, Australia (enrolling)
• Townsville University Hospital — Douglas, Queensland, Australia (enrolling)
• Genesiscare St Andrews — Adelaide, South Australia, Australia (enrolling)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Fundacao Pio Xii Hospital de Amor de Barretos — Barretos, Brazil (enrolling)
• Hospital Sirio Libanes Brasilia — Brasília, Brazil (enrolling)
• Centro de Pesquisas Oncologicas Cepon — Florianópolis, Brazil (enrolling)
• Liga Norte Riograndene Contra O Cancer — Natal, Brazil (enrolling)
• Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude — Petrópolis, Brazil (enrolling)
• Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia — Porto Algre, Brazil (enrolling)
• Instituto Nacional de Cancer — Rio de Janeiro, Brazil (enrolling)
• Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria — São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.