drugset / Trial / NCT05775874
A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
NaSingle-groupOpen-labelTreatment
Summary
This trial is an open, phase II clinical study. The study is divided into two parts: A and B, and the part A evaluate the safety and tolerability of AZD4547 combined with Tislelizumab in patients with locally advanced or metastatic urothelial cancer, determine the recommended dose of midoral AZD4547 combined with Tislelizumab in a Chinese patient population. Part B study will evaluate the efficacy of this recommended dose combined with Tislelizumab in patients with locally advanced or metastatic urothelial cancer with FGFR2 / 3 alterations , and will also further evaluate the safety, tolerability, and PK and PD characteristics of AZD4547 in combination with Tislelizumab.
Timeline
- Start
- 2022-09-30
- Primary completion
- 2025-09-30
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fexagratinib | Small molecule | 60 mg | Oral |
| Subject | Fexagratinib | Small molecule | 80 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |