Brief Summary
This is a dosethe amount of medication taken escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (BC) and other advancedat a late stage, far along solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Intervention / Treatment
- Drug: BGB-43395
- Drug: Fulvestrant
- Drug: Letrozole
Inclusion Criteria
- Phase 1a (Dose Escalation) and 1b (Dose Expansion): 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.
- Phase 1a: Received prior therapy for their condition (if available) and should be refractory to or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor.
- Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types.
- Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells for advanced disease.
- Stable Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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.