drugset / Trial / NCT05775874

A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC

NCT05775874

Phase 2 Unknown 80 enrolled Abbisko Therapeutics Co, Ltd
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

EvaluationDrugModalityDoseRoute
Subject Fexagratinib Small molecule 60 mg Oral
Subject Fexagratinib Small molecule 80 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications