Clinical trials: FGFR Gene Alterations
Advanced Solid Tumor
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
- Trial name
- NCT05372120
- Testing
- ICP-192
- Where
- 37 sites in China
- Volunteers
- 200 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
- Conditions
- Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Non-Small Cell Lung Cancer, KRAS Gene Mutation
- Trial name
- NCT04965818
- Testing
- Futibatinib and Binimetinib
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Taiho Oncology, Inc.
Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3…
- Conditions
- Solid Tumor, Adult, Intrahepatic Cholangiocarcinoma, Urothelial Carcinoma
- Trial name
- NCT05242822
- Testing
- KIN-3248
- Where
- 21 sites in United States, China and 4 more
- Volunteers
- 54 people
- Sponsor
- Kinnate Biopharma
Advanced Solid Tumors, Urothelial Carcinoma
A Study of ICP-192 in Patients With Advanced Solid Tumors
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations.
- Conditions
- Advanced Solid Tumors, Urothelial Carcinoma, Cholangiocarcinoma
- Trial name
- NCT04565275
- Testing
- Drug ICP-192
- Where
- 16 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic…
- Trial name
- NCT02150967
- Testing
- BGJ398 (infigratinib)
- Where
- 37 sites in United States, Belgium and 9 more
- Volunteers
- 143 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult…
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement
- Trial name
- NCT06777316
- Testing
- CGT4859
- Where
- 13 sites in United States, Canada
- Volunteers
- 110 people
- Sponsor
- Cogent Biosciences, Inc.
Metastatic Hepatocellular Carcinoma, Solid Tumors
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic…
- Conditions
- Metastatic Hepatocellular Carcinoma, Solid Tumors, Solid Tumor, Adult, FGFR Gene Amplification
- Trial name
- SURF431 (NCT06915753)
- Testing
- TYRA-430
- Where
- 16 sites in United States, Canada and 2 more
- Volunteers
- 125 people
- Sponsor
- Tyra Biosciences, Inc
Muscle-invasive Bladder Cancer
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR…
- Trial name
- SOGUG-NEOWIN (NCT06511648)
- Testing
- Erdafitinib monotherapy, Cetrelimab and Erdafitinib combination
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Spanish Oncology Genito-Urinary Group
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
FGFR1 Gene Amplification, FGFR1 Gene Mutation
Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by…
- Conditions
- FGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR1 Gene Translocation, FGFR2 Gene Amplification
- Trial name
- NCT04096417
- Testing
- Pemigatinib, Quality-of-Life Assessment
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Academic and Community Cancer Research United
Solid Tumor, FGF Receptor Gene Mutation
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors
The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.
- Conditions
- Solid Tumor, FGF Receptor Gene Mutation, FGF Amplification, FGF Receptor Gene Family Rearrangement
- Trial name
- NCT06022289
- Testing
- Pemigatinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Tianjin Medical University Second Hospital
Advanced Solid Tumor
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations…
- Trial name
- RAGNAR (NCT04083976)
- Testing
- Erdafitinib
- Where
- 179 sites in United States, Argentina and 13 more
- Volunteers
- 316 people
- Sponsor
- Janssen Research & Development, LLC
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic…
- Conditions
- Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma
- Trial name
- SURF301 (NCT05544552)
- Testing
- TYRA-300
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 310 people
- Sponsor
- Tyra Biosciences, Inc
Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma
A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
This phase II study evaluates how well pemigatinib works for the treatment of adult patients with pancreatic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body…
- Conditions
- Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8
- Trial name
- NCT06906562
- Testing
- Pemigatinib, Computed Tomography (CT), Magnetic Resonance Imaging
- Where
- 109 sites in United States
- Volunteers
- 40 people
- Sponsor
- Sameek Roychowdhury
Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally…
- Conditions
- Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor, Metastatic Cholangiocarcinoma
- Trial name
- SURF201 (NCT06160752)
- Testing
- Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tyra Biosciences, Inc
Advanced Malignant Solid Neoplasm, Cholangiocarcinoma
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other…
- Conditions
- Advanced Malignant Solid Neoplasm, Cholangiocarcinoma, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
- Trial name
- NCT04233567
- Testing
- Infigratinib
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Sameek Roychowdhury
Malignant Neoplasm
Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.
This phase II trial studies how well ponatinib hydrochloride works in treating patients with cancer that has spread to other parts of the body (metastatic), has failed previous treatment (refractory), and has one of several…
- Trial name
- NCT02272998
- Testing
- ponatinib hydrochloride, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Sameek Roychowdhury
Non-Small Cell Lung Cancer
A Single-Arm Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients
Primary objective: ● To evaluate the efficacy of pemigatinib in advanced non-small cell lung cancer patients with fibroblast growth factor receptor 1-3 (FGFR 1-3) alterations (including but not limited to FGFR amplification…
- Trial name
- NCT05210946
- Testing
- Pemigatinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Solid Tumours
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1…
- Trial name
- NCT01948297
- Testing
- Debio1347 (CH5183284)
- Where
- 8 sites in United States, Singapore and 3 more
- Volunteers
- 77 people
- Sponsor
- Debiopharm International SA