Molecular Profile Detail

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Profile Name FGFR1 fusion
Gene Variant Detail

FGFR1 fusion (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR1 rearrange leukemia sensitive AZD4547 Preclinical - Cell line xenograft Actionable In a preclinical study, AZD4547 inhibited survival of leukemia cells harboring FGFR1 translocation in culture and in cell line xenograft models (PMID: 27550940). 27550940
FGFR1 rearrange myeloid and lymphoid neoplasms associated with FGFR1 abnormalities sensitive Ponatinib Guideline Actionable Iclusig (ponatinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). detail...
FGFR1 rearrange B-cell acute lymphoblastic leukemia not applicable N/A Guideline Prognostic FGFR1 rearrangements are associated with a poor prognosis in patients with B-cell acute lymphoblastic leukemia (NCCN.org). detail...
FGFR1 rearrange myeloid and lymphoid neoplasms associated with FGFR1 abnormalities sensitive Pemigatinib Guideline Actionable Pemazyre (pemigatinib) is included in guidelines (category 2B) for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). detail...
FGFR1 rearrange childhood B-cell acute lymphoblastic leukemia not applicable N/A Guideline Prognostic FGFR1 rearrangements are associated with a poor prognosis in pediatric patients with B-cell acute lymphoblastic leukemia (NCCN.org). detail...
FGFR1 rearrange lung small cell carcinoma sensitive AZD4547 Preclinical - Cell culture Actionable In a preclinical study, AZD4547 inhibited survival of small cell lung cancer cells harboring FGFR1 translocation in culture (PMID: 27550940). 27550940
FGFR1 rearrange myeloid and lymphoid neoplasms associated with FGFR1 abnormalities sensitive Midostaurin Guideline Actionable Rydapt (midostaurin) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). detail...
FGFR1 rearrange myeloproliferative neoplasm sensitive Dovitinib Preclinical Actionable In a preclinical study, primary cells from 8p11 myeloproliferative syndrome patients harboring FGFR1 rearrangement were sensitive to Dovitinib (TKI258)-induced growth inhibition in culture (PMID: 17698633). 17698633
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 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...
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 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...
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04045613 Phase Ib/II Derazantinib Atezolizumab + Derazantinib Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | AUT 7
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
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 (FIGHT-207) Terminated USA | ITA | FRA | ESP | DEU 6
NCT02608125 Phase I PRN1371 A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma Terminated USA | ESP 0
NCT02872714 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Completed USA | ITA | FRA | ESP | DEU | BEL 5
NCT04172675 Phase II Erdafitinib Gemcitabine Mitomycin C A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Recruiting USA | ITA | FRA | ESP | DEU | BEL 11
NCT02465060 Phase II Erdafitinib Trametinib Crizotinib Sapanisertib AZD4547 Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2
NCT05253807 Phase II Pemigatinib Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration (FIGHT-210) Recruiting USA | ITA | FRA | ESP | DEU 0
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 9
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. Unknown status USA 0
NCT04601857 Phase II Futibatinib + Pembrolizumab Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Recruiting USA | FRA | ESP 0
NCT01948297 Phase I Debio 1347 Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations Terminated USA | ESP 3
NCT02546661 Phase I AZD9150 + Durvalumab Durvalumab + Selumetinib AZD4547 Durvalumab + Olaparib Durvalumab AZD4547 + Durvalumab Durvalumab + Vistusertib Adavosertib + Durvalumab Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (BISCAY) Active, not recruiting USA | FRA | ESP | CAN 1
NCT04233567 Phase II Infigratinib Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Recruiting USA 0
NCT05216120 Phase II Pemigatinib Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas Recruiting USA 0
NCT05316155 Phase I Erdafitinib Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer Recruiting USA | FRA | ESP | DEU 2
NCT02393248 Phase Ib/II Cisplatin + Gemcitabine + Pemigatinib Docetaxel + Pemigatinib Pemigatinib + Retifanlimab Pemigatinib + Trastuzumab Epacadostat + Pembrolizumab Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) Completed USA 1
NCT02052778 Phase Ib/II Futibatinib A Study of TAS-120 in Patients With Advanced Solid Tumors Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN 7
NCT04088188 Phase I Cisplatin + Gemcitabine + Pemigatinib Cisplatin + Gemcitabine + Ivosidenib Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma 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
NCT02160041 Phase II Infigratinib BGJ398 for Patients With Tumors With FGFR Genetic Alterations Terminated USA 0