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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
NCT04917809 Phase II Erdafitinib A Study of Oral 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Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial Withdrawn 0
NCT05627063 Phase I ABSK121 A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors Recruiting USA 1
NCT02846766 Phase II Lenvatinib Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling Withdrawn USA 0
NCT04972253 Phase I Infigratinib Phase I BLASST-3 Trial ((BLASST)-3) Withdrawn 0
NCT06160752 Phase I TYRA-200 Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations (SURF201) Recruiting USA 0
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Active, not recruiting USA 0
NCT02299141 Phase I Nintedanib Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer Active, not recruiting 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
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
NCT04092673 Phase Ib/II Fulvestrant + Zotatifin Zotatifin Sotorasib + Zotatifin Abemaciclib + Fulvestrant + Zotatifin Trastuzumab + Zotatifin Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies (Zotatifin) Recruiting USA 0
NCT04233567 Phase II Infigratinib Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Active, not recruiting USA 0
NCT01975701 Phase II Infigratinib A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed USA | NLD | ESP | BEL | AUS 1
NCT02925234 Phase II Palbociclib Ribociclib Lenvatinib Ipilimumab + Nivolumab Trametinib Crizotinib Niraparib Selpercatinib Olaparib Erlotinib Erdafitinib Dabrafenib Dacomitinib Rucaparib Axitinib Panitumumab Pemigatinib Durvalumab Afatinib Entrectinib Tepotinib Alpelisib Atezolizumab + Bevacizumab Alectinib Regorafenib Cobimetinib + Vemurafenib Nilotinib Vismodegib Abemaciclib Sunitinib Nivolumab Cabozantinib Lorlatinib Talazoparib Dabrafenib + Trametinib Pembrolizumab Pertuzumab + Trastuzumab The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting NLD 0
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
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
NCT02160041 Phase II Infigratinib BGJ398 for Patients With Tumors With FGFR Genetic Alterations Terminated USA 0
NCT03344536 Phase Ib/II Debio 1347 + Fulvestrant A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer Completed 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
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. Active, not 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
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
NCT02872714 Phase II Pemigatinib A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL 3
NCT04424966 Phase 0 Infigratinib Infigratinib in Recurrent High-Grade Glioma Patients Terminated USA 0
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 3
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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT 7
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 | CAN | AUS 1
NCT05216120 Phase II Pemigatinib Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas Withdrawn USA 0
NCT01004224 Phase I Infigratinib A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies Completed USA | NLD | ITA | FRA | ESP | DEU | AUT | AUS 6
NCT02529553 Phase I LY3076226 A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Completed USA | CAN 0
NCT04565275 Phase Ib/II ICP-192 A Study of ICP-192 in Patients With Advanced Solid Tumors Recruiting USA | AUS 0
NCT02312804 Phase I Paclitaxel Carboplatin Infigratinib Ph Ib/BGJ398/Cervix and Other Solid Tumors Withdrawn 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
NCT01928459 Phase I Alpelisib + Infigratinib Phase 1b Trial of BGJ398/BYL719 in Solid Tumors Completed USA | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS 3
NCT04601857 Phase II Futibatinib + Pembrolizumab Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma Active, not recruiting USA | FRA | ESP 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
NCT04045613 Phase Ib/II Derazantinib Atezolizumab + Derazantinib Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 5
NCT02747797 Phase II Lucitanib Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations Withdrawn USA 0
NCT01831726 Phase II Dovitinib Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Completed USA 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
NCT04294277 Phase II Pemigatinib Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) Terminated ITA 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) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS 9
NCT04083976 Phase II Erdafitinib A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (RAGNAR) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS 7
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 | GBR | ESP 5
NCT05242822 Phase I KIN-3248 A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations Active, not recruiting USA | ESP 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 | GBR | FRA | ESP | DEU 5
NCT03934372 Phase Ib/II Ponatinib Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors Recruiting NLD | ITA | GBR | FRA | ESP | DEU | BEL 2
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 | GBR | FRA | ESP | DEU | BEL | AUS 7
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) Active, not recruiting USA 0
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) (CAPTUR) Recruiting 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) Active, not recruiting USA 1
NCT02546661 Phase I Danvatirsen + 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 | GBR | FRA | ESP | CAN 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 Active, not recruiting USA 0
NCT05363605 Phase Ib/II 225Ac-FPI-1966 + Vofatamab A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours Terminated USA | AUS 0
NCT04483505 Phase I Fulvestrant + Palbociclib + Rogaratinib Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. (ROGABREAST) Completed ESP 0
NCT03834220 Phase II Debio 1347 Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Terminated USA | NLD | GBR | FRA | ESP | AUT | AUS 16
NCT05316155 Phase I Erdafitinib Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer Recruiting USA | NLD | ESP | DEU 1
NCT02657486 Phase 0 Infigratinib BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder Active, not recruiting USA 0
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 2
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 | AUS 0
NCT05244551 Phase I ABSK061 A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors Recruiting USA 1
NCT02052778 Phase Ib/II Futibatinib A Study of TAS-120 in Patients With Advanced Solid Tumors Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS 4
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) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU 2
NCT06302621 Phase I Afatinib + Pemigatinib Pemigatinib + Afatinib in Advanced Refractory Solid Tumors Not yet recruiting USA 0
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) Completed USA | ITA | FRA | ESP | DEU 0
NCT05614739 Phase I LOXO-435 + Pembrolizumab LOXO-435 A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3 Recruiting USA | NLD | GBR | FRA | ESP | DEU | CAN | AUS 3
NCT03827850 Phase II Erdafitinib FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) Terminated DEU 0
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) Unknown status 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
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
NCT01976741 Phase I Rogaratinib Phase I Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor Completed USA | FRA | ESP | DEU 3
NCT04040725 Phase II Rogaratinib Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression Withdrawn 0
NCT06263153 Phase II Durvalumab + Futibatinib Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy Not yet recruiting USA 0
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 18
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) Active, not recruiting ITA | GBR | FRA | ESP | BEL 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
NCT04189445 Phase II Futibatinib Futibatinib in Patients With Specific FGFR Aberrations Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | BEL 7
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 | AUS 0