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A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC - Trial NCT05775874

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.

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NCT05775874
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05775874
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A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
A Sigle-arm๏ผŒOpen Label๏ผŒMulticenter Study of AZD4547 Combination With Tislelizumab for Patients With Metastatic or Locally Advanced Urothelial Carcinoma (mUC) Harboring Fibroblast Growth Factor Receptor Alterations

Study Focus

Urothelial Carcinoma

AZD4547

Interventional

drug

Sponsor & Location

Abbisko Therapeutics Co, Ltd

Shanghai, China

Timeline & Enrollment

Phase 2

Sep 30, 2022

Dec 30, 2025

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 organs
Malignant neoplasm of ureter
Malignant neoplasms of urinary tract
Malignant neoplasm: Overlapping lesion of urinary organs
Malignant neoplasm: Urethra

Data Source

ClinicalTrials.gov

NCT05775874

Non-Device Trial