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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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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | ISR | GBR | FRA | ESP | DNK | DEU | CHE 2
NCT01976741 Phase I Rogaratinib Phase I Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor Completed USA | FRA | ESP | DEU | CHE 2
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 | NOR | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CAN | AUS 3
NCT04923126 Phase Ib/II Mirdametinib SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma Recruiting USA 0
NCT06319820 Phase III Mitomycin C Gemcitabine Erdafitinib A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer (MoonRISe-1) Recruiting USA | TUR | POL | ITA | ISR | IRL | GBR | FRA | ESP | DNK | DEU | CZE | BRA | BEL | AUT | ARG 4
NCT05244551 Phase I ABSK061 A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patients With Advanced Solid Tumors Recruiting USA 1
NCT02925234 Phase II Niraparib Tepotinib Erdafitinib Ivosidenib Panitumumab Pemigatinib The Drug Rediscovery Protocol (DRUP Trial) (DRUP) Recruiting NLD 0
NCT03390504 Phase III Pembrolizumab Erdafitinib Docetaxel + Vinflunine A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (THOR) Active, not recruiting USA | TUR | POL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BGR | BEL | AUT | AUS | ARG 8
NCT04096417 Phase II Pemigatinib Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Unknown status USA 0
NCT06302621 Phase I Afatinib + Pemigatinib Pemigatinib + Afatinib in Advanced Refractory Solid Tumors Recruiting USA 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) Completed 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
NCT03767075 Phase II Amivantamab-vmjw Futibatinib Atezolizumab A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets) (BoB) Recruiting SWE | NLD | ITA | GBR | FRA | ESP | DEU 0
NCT06906562 Phase II Pemigatinib A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations 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 | AUS 0
NCT05176665 Phase Ib/II EMB-01 EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers Recruiting USA 1
NCT05804227 Phase I Ulixertinib Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Gliomas Recruiting USA 0
NCT01975701 Phase II Infigratinib A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed USA | NLD | ESP | CHE | BEL | AUS 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 | GRC | GBR | FRA | ESP | DEU | CAN | BGR | BEL 0
NCT05316155 Phase I Erdafitinib Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer Recruiting USA | NLD | ISR | ESP | DEU | CAN 2
NCT06995677 Phase II TYRA-300 Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302) Recruiting USA 0
NCT02657486 Phase 0 Infigratinib BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder Active, not 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) Terminated USA | NLD | ITA | GBR | FRA | ESP | DNK | DEU 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
NCT04917809 Phase II Erdafitinib A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer Active, not recruiting 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. Completed 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 Active, not recruiting USA | CAN 0
NCT03827850 Phase II Erdafitinib FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) Terminated DEU 0
NCT06915753 Phase I TYRA-430 Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations (SURF431) Recruiting USA | CAN 2
NCT06874335 Phase I BHV-1530 A Phase 1 Study of BHV-1530 (AMB302) in Advanced Solid Tumors Recruiting USA 0
NCT05627063 Phase I ABSK121 A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors Active, not recruiting USA 1