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NCT05775874

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

A Sigle-arm，Open Label，Multicenter Study of AZD4547 Combination With Tislelizumab for Patients With Metastatic or Locally Advanced Urothelial Carcinoma (mUC) Harboring Fibroblast Growth Factor Receptor Alterations
Abbisko Therapeutics Co, Ltd·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Urothelial Carcinoma
Drug/Device/Intervention
AZD4547
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Abbisko Therapeutics Co, Ltd
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 2
Start date
Sep 30, 2022
End date
Dec 30, 2025
Enrollment
80 participants
Primary outcome

Safety index,Effectiveness indicators

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.

ICD-10 classifications
Carcinoma in situ: Other and unspecified urinary organsMalignant neoplasm of ureterMalignant neoplasms of urinary tractMalignant neoplasm: Overlapping lesion of urinary organsMalignant neoplasm: Urethra
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05775874
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05775874 through Pure Global AI's free database. This Phase 2 trial is sponsored by Abbisko Therapeutics Co, Ltd and is currently Recruiting. The study focuses on Urothelial Carcinoma. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.