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NCT05086666

A Phase 1b/2 Clinical Study to Evaluate the Safety and Tolerability and Efficacy of AZD4547

Status unknown Phase 1, PHASE2 Last updated 21 October 2021
What this trial tests

Phase 1, PHASE2 trial testing AZD4547 in Urothelial Carcinoma in 108 participants. Status unknown.

Timeline
3 June 2021
Primary endpoint
14 August 2023
27 May 2024

Quick facts

Lead sponsorAbbisko Therapeutics Co, Ltd
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment108
Start date3 June 2021
Primary completion14 August 2023
Estimated completion27 May 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Abbisko Therapeutics Co, Ltd — full company profile →

Who can join

25 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase 1b clinical study to evaluate the PK of oral AZD4547 in Chinese patients and RP2D. Phase 2 study to evaluate the efficacy of AZD4547 in urothelial carcinoma patients with FGFR2/3 gene alterations.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinically relevant fusion oncogenes: detection and practical implications.
    Sorokin M, Rabushko E, Rozenberg JM, Mohammad T, et al · · 2022 · cited 25× · PMID 36601633 · DOI 10.1177/17588359221144108
  2. Targeting FGFR2 Positive Gastroesophageal Cancer: Current and Clinical Developments.
    Gordon A, Johnston E, Lau DK, Starling N. · · 2022 · cited 25× · PMID 36238135 · DOI 10.2147/ott.s282718
  3. Fibroblast growth factor receptors as targets for anticancer therapy in cholangiocarcinomas and urothelial carcinomas.
    Wekking D, Pretta A, Martella S, D'Agata AP, et al · · 2023 · cited 10× · PMID 37681152 · DOI 10.1016/j.heliyon.2023.e19541
  4. Fibroblast Growth Factor Receptor Inhibitors Decrease Proliferation of Melanoma Cell Lines and Their Activity Is Modulated by Vitamin D.
    Piotrowska A, Nowak JI, Wierzbicka JM, Domżalski P, et al · · 2024 · cited 3× · PMID 38473753 · DOI 10.3390/ijms25052505
  5. Scientific advances in drug development and clinical trials for urothelial carcinoma: Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium
    · 2025

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Other trials of AZD4547

Trials testing the same drug.

Other recruiting trials for Urothelial Carcinoma

Currently open trials in the same condition.

Other Abbisko Therapeutics Co, Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05086666.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing