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Gene Symbol | FGFR3 | ||||||||||
Synonyms | ACH | CD333 | CEK2 | HSFGFR3EX | JTK4 | ||||||||||
Gene Description | FGFR3, fibroblast growth factor receptor 3, is a receptor tyrosine kinase activated upon binding of the FGF ligand, which activates RAS-MAPK and PI3K-AKT pathways (PMID: 22508544). Altered function of FGFR3 in cancer may lead to increased cell proliferation and decreased apoptosis (PMID: 22508544) and mutations and fusions are commonly observed in bladder cancer (PMID: 30975452, PMID: 23175443), while FGFR3 overexpression only in bladder cancer may have different treatment implications (PMID: 32682615). | ||||||||||
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02846766 | Phase II | Lenvatinib | Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling | Withdrawn | USA | 0 |
NCT04096417 | Phase II | Pemigatinib | Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations | Active, not recruiting | USA | 0 |
NCT04092673 | Phase Ib/II | eFT226 + Fulvestrant eFT226 eFT226 + Sotorasib Abemaciclib + eFT226 + Fulvestrant eFT226 + Trastuzumab | Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies (Zotatifin) | Recruiting | USA | 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 |
NCT02299141 | Phase I | Nintedanib | Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
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 |
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 |
NCT04233567 | Phase II | Infigratinib | Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations | Recruiting | USA | 0 |
NCT03238196 | Phase I | Erdafitinib + Fulvestrant + Palbociclib | Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
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) | Terminated | USA | 1 |
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 |
NCT03344536 | Phase Ib/II | Debio 1347 + Fulvestrant | A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer | Completed | USA | 0 |
NCT02558348 | Phase Ib/II | Anlotinib | Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001) | Terminated | USA | 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 |
NCT02160041 | Phase II | Infigratinib | BGJ398 for Patients With Tumors With FGFR Genetic Alterations | Terminated | USA | 0 |
NCT01975701 | Phase II | Infigratinib | A Phase 2 Study of BGJ398 in Patients With Recurrent GBM | Completed | USA | ESP | BEL | 3 |
NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) | Recruiting | USA | 0 |
NCT04917809 | Phase II | Erdafitinib | A Study of Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer | Recruiting | USA | 0 |
NCT05564416 | Phase II | Erdafitinib Atezolizumab + Erdafitinib | Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial | Recruiting | CAN | 0 |
NCT04972253 | Phase I | Infigratinib | Phase I BLASST-3 Trial ((BLASST)-3) | Withdrawn | 0 | |
NCT04424966 | Phase 0 | Infigratinib | Infigratinib in Recurrent High-Grade Glioma Patients | Active, not recruiting | USA | 0 |
NCT03517956 | Phase I | Copanlisib + Rogaratinib | Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors (ROCOCO) | Completed | USA | ESP | DEU | BEL | 2 |
NCT03473756 | Phase Ib/II | Atezolizumab Atezolizumab + Rogaratinib | Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (FORT-2) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | AUT | 2 |
NCT03410693 | Phase II | Docetaxel Vinflunine Paclitaxel Rogaratinib | Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1) | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 21 |
NCT04040725 | Phase II | Rogaratinib | Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression | Withdrawn | 0 | |
NCT03088059 | Phase II | Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil | Biomarker-based Study in R/M SCCHN (UPSTREAM) | Recruiting | ITA | FRA | BEL | 1 |
NCT04483505 | Phase I | Fulvestrant + Palbociclib + Rogaratinib | Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. (ROGABREAST) | Active, not recruiting | ESP | 0 |
NCT02952573 | Phase II | Dexamethasone + Erdafitinib | Testing JNJ-42756493 In Combination With Dexamethasone in Multiple Myeloma That Came Back After a Period of Improvement | Terminated | CAN | 0 |
NCT05363605 | Phase Ib/II | 225Ac-FPI-1966 + Vofatamab | A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours | Recruiting | USA | 1 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |
NCT02747797 | Phase II | Lucitanib | Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations | Withdrawn | USA | 0 |
NCT04045613 | Phase Ib/II | Derazantinib Atezolizumab + Derazantinib | Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) | Completed | USA | ITA | FRA | ESP | DEU | CAN | AUT | 7 |
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 |
NCT04595747 | Phase II | Rogaratinib | Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST) | Recruiting | USA | 0 |
NCT03934372 | Phase Ib/II | Ponatinib | Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors | Recruiting | ITA | FRA | ESP | DEU | BEL | 4 |
NCT01004224 | Phase I | Infigratinib | A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies | Completed | USA | ITA | FRA | ESP | DEU | AUT | 8 |
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 |
NCT05242822 | Phase I | KIN-3248 | A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations | Recruiting | USA | 1 |
NCT04003610 | Phase II | Pembrolizumab + Pemigatinib Pembrolizumab Carboplatin + Gemcitabine Pemigatinib | Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) | Terminated | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 8 |
NCT04601857 | Phase II | Futibatinib + Pembrolizumab | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Recruiting | USA | FRA | ESP | 0 |
NCT02312804 | Phase I | Paclitaxel Carboplatin Infigratinib | Ph Ib/BGJ398/Cervix and Other Solid Tumors | Withdrawn | 0 | |
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 |
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 |
NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) | Recruiting | CAN | 0 |
NCT01928459 | Phase I | Alpelisib + Infigratinib | Phase 1b Trial of BGJ398/BYL719 in Solid Tumors | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
NCT04294277 | Phase II | Pemigatinib | Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) | Terminated | ITA | 0 |
NCT02401542 | Phase Ib/II | Docetaxel + Vofatamab Vofatamab Docetaxel | Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (FIERCE-21) | Terminated | USA | ITA | ESP | 6 |
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 | BEL | 9 |
NCT02529553 | Phase I | LY3076226 | A Study of LY3076226 in Participants With Advanced or Metastatic Cancer | Completed | USA | CAN | 0 |
NCT03210714 | Phase II | Erdafitinib | Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) | Suspended | USA | 1 |
NCT04604132 | Phase Ib/II | Atezolizumab + Derazantinib Derazantinib + Paclitaxel + Ramucirumab Derazantinib Paclitaxel + Ramucirumab | Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (FIDES-03) | Terminated | USA | ITA | FRA | ESP | DEU | BEL | 9 |
NCT04463771 | Phase II | Pemigatinib + Retifanlimab Epacadostat + Retifanlimab Retifanlimab | Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204) | Recruiting | USA | ITA | FRA | DEU | BEL | 2 |
NCT04565275 | Phase Ib/II | ICP-192 | A Study of ICP-192 in Patients With Advanced Solid Tumors | Recruiting | USA | 1 |
NCT04003623 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | Terminated | USA | 0 |
NCT04504331 | Phase I | Fulvestrant + Infigratinib + Palbociclib Infigratinib + Tamoxifen | Study of Infigratinib in Combination With Tamoxifen or With Fulvestrant and Palbociclib in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer | Terminated | USA | 0 |
NCT01831726 | Phase II | Dovitinib | Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib | Completed | USA | 0 |
NCT05216120 | Phase II | Pemigatinib | Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas | 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 |
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 |
NCT04189445 | Phase II | Futibatinib | Futibatinib in Patients With Specific FGFR Aberrations | Active, not recruiting | USA | ITA | FRA | ESP | DEU | BEL | 9 |
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 |
NCT04197986 | Phase III | Infigratinib | Study of Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations | Terminated | USA | ITA | FRA | ESP | DEU | CAN | BEL | 4 |
NCT04923126 | Phase Ib/II | PD-0325901 | SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma | Recruiting | USA | 0 |
NCT05544552 | Phase Ib/II | TYRA-300 | Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations (SURF301) | Recruiting | USA | FRA | ESP | 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 |
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) | Recruiting | USA | 0 |
NCT01976741 | Phase I | Rogaratinib | Phase I Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor | Completed | USA | FRA | ESP | DEU | 3 |
NCT05614739 | Phase I | LOXO-435 + Pembrolizumab LOXO-435 | A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3 | Recruiting | USA | 0 |
NCT05244551 | Phase I | ABSK061 | A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors | Recruiting | USA | 1 |
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 |
NCT05316155 | Phase I | Erdafitinib | Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer | Recruiting | USA | ESP | DEU | 2 |
NCT04963153 | Phase I | Enfortumab vedotin-ejfv + Erdafitinib | Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy | Recruiting | USA | 0 |
NCT03827850 | Phase II | Erdafitinib | FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) | Unknown status | DEU | 0 |
NCT02657486 | Phase 0 | Infigratinib | BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder | Active, not recruiting | USA | 0 |