Molecular Profile Detail

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Profile Name FGFR3 act mut
Gene Variant Detail

FGFR3 act mut (gain of function)

Relevant Treatment Approaches FGFR Inhibitor (Pan) FGFR3 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 act mut Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) Ponatinib Preclinical Actionable In a preclinical study, Iclusig (ponatinib) inhibited receptor phosphorylation and cell growth in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor predicted - sensitive FGFR3 Inhibitor AZD4547 Phase II Actionable In a Phase II (MATCH) trial, AZD4547 treatment resulted in an overall response rate of 10.5% (2/19) in patients with advanced solid tumors harboring FGFR2 or 3 activating single nucleotide variants and a 6-month progression-free survival rate of 6%, with a partial response in 1 and stable disease in 2 of 7 patients with FGFR3 activating mutations (PMID: 32463741; NCT02465060). 32463741
FGFR3 act mut Advanced Solid Tumor sensitive FGFR Inhibitor (Pan) Dovitinib Preclinical Actionable In a preclinical study, Dovitinib (TKI258) inhibited receptor phosphorylation and cell proliferation in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor decreased response FGFR Inhibitor (Pan) Nintedanib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to Ofev (Nintedanib) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor no benefit Brivanib Preclinical Actionable In a preclinical study, Brivanib (BMS-540215) did not inhibit receptor phosphorylation and cell proliferation in transformed cells expressing constitutively active FGFR3 in culture (PMID: 22238366). 22238366
FGFR3 act mut Advanced Solid Tumor predicted - sensitive FGFR Inhibitor (Pan) Erdafitinib Phase I Actionable In a Phase I trial, Balversa (erdafitinib) treatment resulted in stable disease in 70% (16/23) and partial response in 22% (5/23) of patients with advanced solid tumors harboring FGFR 1-4 activating mutations (including amplifications, mutations and translocations), while no antitumor activity was observed in patients with unknown or no known changes in FGFR (PMID: 26324363; NCT01703481). 26324363
FGFR3 act mut Advanced Solid Tumor sensitive FGFR3 Inhibitor Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR3 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). detail...
FGFR3 act mut urinary bladder cancer predicted - sensitive FGFR3 Inhibitor S-49076 Preclinical Actionable In a preclinical study, S-49076 inhibited autophosphorylation of FGFR3 and downstream signaling in bladder cancer cells over expressing constitutively active FGFR3 in culture (PMID: 23804704). 23804704
FGFR3 act mut Advanced Solid Tumor decreased response Cediranib Preclinical Actionable In a preclinical study, transformed cells expressing constitutively active FGFR3 demonstrated reduced sensitivity to inhibition of receptor phosphorylation and cell proliferation by Cediranib (AZD-2171) in culture, when compared to other tyrosine kinase inhibitors (PMID: 22238366). 22238366
Clinical Trial Phase Therapies Title Recruitment Status
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Not yet recruiting
NCT02052778 Phase Ib/II Futibatinib A Study of TAS-120 in Patients With Advanced Solid Tumors Active, not recruiting
NCT01975701 Phase II Infigratinib A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed
NCT03822117 Phase II Pemigatinib Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations Recruiting
NCT03732703 Phase Ib/II Dexamethasone + Enasidenib + Ixazomib + Pomalidomide Cobimetinib + Dexamethasone + Ixazomib + Pomalidomide Dexamethasone + Erdafitinib + Ixazomib + Pomalidomide Dexamethasone + Ixazomib + Pomalidomide + Venetoclax Abemaciclib + Dexamethasone + Ixazomib + Pomalidomide Daratumumab + Dexamethasone + Ixazomib + Pomalidomide Myeloma-Developing Regimens Using Genomics (MyDRUG) (MyDRUG) Recruiting
NCT02657486 Phase 0 Infigratinib BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder Active, not recruiting
NCT04197986 Phase III Infigratinib Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations Recruiting
NCT02272998 Phase II Ponatinib Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT. Recruiting
NCT01976741 Phase I Rogaratinib Phase I Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor Completed