drugset / Trial / NCT06253195
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2026-04-23
- Completion
- 2026-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BGB-43395 | Unknown | — | Oral |
| Subject | Fulvestrant | Small molecule | — | Intramuscular |
| Subject | Letrozole | Other / unclassified | — | Oral |