Molecular Profile Detail

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Profile Name FGFR1 rearrange
Gene Variant Detail

FGFR1 rearrange (unknown)

Relevant Treatment Approaches FGFR Inhibitor (Pan)

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR1 mutant Advanced Solid Tumor predicted - sensitive ICP-192 Phase I Actionable In a Phase I trial, ICP-192 (gunagratinib) was well-tolerated, and resulted in an overall response rate or 33.3% (4/12, 1 complete response, 3 partial response) and a disease control rate of 91.7% (11/12) in patients with advanced solid tumors harboring FGF/FGFR gene aberrations (J Clin Oncol 39, 2021 (suppl 15; abstr 4092); NCT03758664). detail...
FGFR1 mutant Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR1 mutant Advanced Solid Tumor sensitive Pemigatinib Preclinical - Cell line xenograft Actionable In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). detail...
FGFR1 mutant transitional cell carcinoma predicted - sensitive Erdafitinib Phase II Actionable In a Phase II trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). detail...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04294277 Phase II Pemigatinib Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) Active, not recruiting ITA 0
NCT03011372 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 3
NCT01975701 Phase II Infigratinib A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed USA | ESP | BEL 3
NCT02706691 Phase II Infigratinib Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer Terminated USA 0
NCT03801434 Phase II Ruxolitinib Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders Recruiting USA 0
NCT03834220 Phase II Debio 1347 Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Terminated USA | FRA | ESP | AUT 19
NCT04233567 Phase II Infigratinib Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Recruiting USA 0
NCT03611868 Phase Ib/II APG-115 + Pembrolizumab A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Recruiting USA 1
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed USA 0
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Active, not recruiting USA 0
NCT03862157 Phase Ib/II Azacitidine + MLN4924 + Venetoclax Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Active, not recruiting USA 0
NCT02268253 Phase II Tagraxofusp-erzs Tagraxofusp (SL-401) in Patients With CMML or MF Recruiting USA | CAN 0
NCT04189445 Phase II Futibatinib Futibatinib in Patients With Specific FGFR Aberrations Recruiting USA | ITA | FRA | ESP | DEU | BEL 9
NCT05216120 Phase II Pemigatinib Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas Recruiting USA 0
NCT04003623 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) Terminated USA 0
NCT04923126 Phase Ib/II PD-0325901 SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Recruiting USA 0
NCT05267106 Phase II Pemigatinib Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209) Recruiting USA | ITA | FRA | ESP | DEU 4
NCT04601857 Phase II Futibatinib + Pembrolizumab Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Recruiting USA | FRA | ESP 0