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NCT05086666
A Phase 1b/2 Clinical Study to Evaluate the Safety and Tolerability and Efficacy of AZD4547
Phase 1, PHASE2 trial testing AZD4547 in Urothelial Carcinoma in 108 participants. Status unknown.
14 August 2023
Quick facts
| Lead sponsor | Abbisko Therapeutics Co, Ltd |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 3 June 2021 |
| Primary completion | 14 August 2023 |
| Estimated completion | 27 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- AZD4547 (azd4547) — full drug profile →
Conditions studied
- Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
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):
-
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 -
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 -
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 -
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 -
Scientific advances in drug development and clinical trials for urothelial carcinoma: Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium
· 2025
Verify or expand the search:
- PubMed search for NCT05086666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD4547
Trials testing the same drug.
- NCT05775874 — A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC · Phase 2 · unknown
- NCT02546661 — Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer · Phase 1 · active not recruiting
- NCT00979134 — Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours · Phase 1 · terminated
Other recruiting trials for Urothelial Carcinoma
Currently open trials in the same condition.
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
- NCT07421700 — Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer · Phase 1, PHASE2 · recruiting
- NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
- NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting
Other Abbisko Therapeutics Co, Ltd trials
Trials by the same sponsor.
- NCT07417189 — A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) · Phase 1, PHASE2 · recruiting
- NCT07297875 — A Study of ABSK061 to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy in Children With Achondroplasia · Phase 1, PHASE2 · not yet recruiting
- NCT07164170 — A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib · Phase 2 · not yet recruiting
- NCT07210996 — A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions i · Phase 1 · completed
- NCT07288957 — A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05086666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbisko Therapeutics Co, Ltd
- Last refreshed: 21 October 2021
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