drugset / Trial / NCT06120283
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-12-01
- Primary completion
- 2028-11
- Completion
- 2028-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGB-43395 | Unknown | — | Oral |
| Subject | Elacestrant | Other / unclassified | — | Oral |
| Subject | Fulvestrant | Small molecule | — | Intramuscular |
| Subject | Letrozole | Other / unclassified | — | Oral |