drugset / Trial / NCT07288359
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
RandomizedSequentialOpen-labelTreatment
Summary
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation. Phase II: Further characterize the safety and tolerability of GVV858 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Timeline
- Start
- 2025-12-29
- Primary completion
- 2031-05-09
- Completion
- 2031-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | — | — |
| Subject | GVV858 | Unknown | — | — |
| Subject | Letrozole | Other / unclassified | — | — |