drugset / Trial / NCT05384119
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2)- palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI or fulvestrant. The primary objective of Phase 2 will be to evaluate anti-tumor activity in participants who receive TTI-101 added to palbociclib or ribociclib and AI or fulvestrant.
Timeline
- Start
- 2023-01-09
- Primary completion
- 2024-04-25
- Completion
- 2024-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | C-188-9 | Small molecule | — | Oral |
| Background | Fulvestrant | Small molecule | — | Oral |
| Background | Palbociclib | Small molecule | — | Oral |
| Background | Ribociclib | Small molecule | — | Oral |