Infigratinib
Sponsors
QED Therapeutics Inc., Qed Therapeutics Inc., Qed Therapeutics Inc., QED Therapeutics, a BridgeBio company, M.D. Anderson Cancer Center, Sameek Roychowdhury
Conditions
AchondroplasiaAdvanced Malignant Solid NeoplasmAdvanced Solid TumorBladder CancerBladder Transitional Cell CarcinomaBreast CancerCNS TumorCholangiocarcinoma
Early Phase 1
Phase 1
Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer
TerminatedNCT04228042
Start: 2020-07-28End: 2024-04-17Updated: 2025-01-01
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
TerminatedNCT04504331
Start: 2020-10-13End: 2021-10-22Updated: 2026-02-12
Phase I BLASST-3 Trial
WithdrawnNCT04972253
Start: 2021-12-23End: 2023-12-31Updated: 2022-08-10
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
WithdrawnNCT05222165
Start: 2021-10-01End: 2022-12-16Updated: 2023-02-23
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification
WithdrawnNCT05510427
Start: 2023-08-07End: 2023-08-07Updated: 2023-08-15
Phase 2
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
CompletedNCT04233567
Start: 2020-01-16End: 2024-12-12Updated: 2026-02-24
Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
NCT05019794
Start: 2020-05-13End: 2023-12-30Target: 80Updated: 2022-06-27
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Enrolling by invitationNCT05145010
Start: 2021-12-06End: 2032-02-01Target: 300Updated: 2025-10-31
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
TerminatedNCT06206278
Start: 2023-10-19End: 2024-05-31Updated: 2024-08-14
Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE
RecruitingCTIS2024-513857-55-00
Start: 2022-02-08Target: 72Updated: 2026-01-27
Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE
RecruitingCTIS2024-513857-55-00
Start: 2022-02-08Target: 72Updated: 2026-01-27
A Phase 2/3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children with Hypochondroplasia: ACCEL 2/3
RecruitingCTIS2024-516822-67-00
Start: 2025-08-14Target: 32Updated: 2026-01-21
A Phase 2/3, Multicenter, Open-Label Phase Followed by a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children with Hypochondroplasia: ACCEL 2/3
RecruitingCTIS2024-516822-67-00
Start: 2025-08-14Target: 32Updated: 2026-01-21
Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Preceded by a Single Ascending Dose Portion and a Phase 2 Open-Label Portion, to Evaluate the Safety and Efficacy of Oral Infigratinib in Infants and Young Children with Achondroplasia
Not yet recruitingCTIS2024-518072-31-00
Target: 11Updated: 2026-01-16
Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia
Enrolling by invitationNCT07393373
Start: 2026-04-21End: 2036-05-31Target: 135Updated: 2026-02-06
Phase 3
Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations
TerminatedNCT04197986
Start: 2020-03-11End: 2023-02-28Updated: 2024-03-13
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age with Achondroplasia: PROPEL 3
CompletedCTIS2023-506130-67-00
Start: 2024-08-20End: 2025-12-13Target: 62Updated: 2025-12-05
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age with Achondroplasia: PROPEL 3
CompletedCTIS2023-506130-67-00
Start: 2024-08-20End: 2025-12-13Target: 62Updated: 2025-12-05