CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 80 target
Drug / intervention
AZD4547 +1 moredrug
Likely dose
AZD4547 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05775874
NCT05775874Phase 2Unknown
CompareCT.gov

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·interventional·Posted Mar 20, 2023·Updated Mar 20, 2023

In Brief

A Phase 2 clinical trial evaluating AZD4547 and Tislelizumab for Urothelial Carcinoma. Targeting 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2023202420252026
First PostedMar 20, 2023
Enrollment StartSep 30, 2022
Primary CompletionSep 30, 2025
Study CompletionDec 30, 2025
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 3.3 years ago

Interventions

AZD4547drug

Initiation dose: 80mg BID,po.

Tislelizumabdrug

Tislelizumab:200mg Q3W