drugset / Trial / NCT03471663
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Timeline
- Start
- 2018-03-18
- Primary completion
- 2023-10-18
- Completion
- 2023-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TARAGARESTRANT | Small molecule | — | Oral |
| Background | Palbociclib | Small molecule | — | — |