drugset / Trial / NCT07570966
Study of ERW316 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 ERW316 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 ERW316 in combination with fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2031-08-01
- Completion
- 2031-08-01
Outcome
Outcome not reported
Stopped (Business): “Business decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ERW316 | Unknown | — | Oral |
| Subject | Fulvestrant | Small molecule | — | Intramuscular |
| Subject | Letrozole | Other / unclassified | — | Oral |