Clinical trials: FGFR2 Gene Rearrangement
FGFR2 Gene Fusion/Rearrangement, Other Solid Tumors, Adult
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma)…
- Trial name
- ReFocus202 (NCT07359820)
- Testing
- Lirafugratinib
- Where
- 19 sites in United States, France and 3 more
- Volunteers
- 30 people
- Sponsor
- Elevar Therapeutics
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
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.
Unresectable Cholangiocarcinoma, Advanced/Metastatic Cholangiocarcinoma
A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy
The purpose of this study is to confirm the efficacy and safety of pemigatinib in participants with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 fusion or rearrangements after at least 1 prior line…
- Trial name
- FIGHT-214 (NCT07862998)
- Testing
- Pemigatinib
- Volunteers
- 72 people
- Sponsor
- Incyte Corporation
Advanced Cholangiocarcinoma
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
- Trial name
- NCT04507503
- Testing
- TAS-120
- Where
- 16 sites in United States
- Sponsor
- Taiho Oncology, Inc.
Intrahepatic Cholangiocarcinoma (ICC)
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The purpose of this study is to evaluate the efficacy and safety in patients with FGFR2-Rearranged unresectable or metastatic intrahepatic…
- Trial name
- NCT05678270
- Testing
- ICP-192
- Where
- 44 sites in China
- Volunteers
- 70 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Advanced Cholangiocarcinoma, FGFR2 Fusions
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene…
- Conditions
- Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
- Trial name
- FOENIX-CCA4 (NCT05727176)
- Testing
- TAS-120
- Where
- 65 sites in United States, Argentina and 11 more
- Volunteers
- 120 people
- Sponsor
- Taiho Oncology, Inc.
Advanced Cholangiocarcinoma, FGFR2 Gene Rearrangements
Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced…
- Trial name
- FOENIX-CCA3 (NCT04093362)
- Testing
- Futibatinib, Cisplatin, Gemcitabine
- Where
- 103 sites in United States, Argentina and 18 more
- Volunteers
- 10 people
- Sponsor
- Taiho Oncology, Inc.
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
Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma
Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations
This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or…
- Trial name
- NCT07328919
- Testing
- TT-00420 (tinengotinib), Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine
- Where
- 20 sites in China
- Volunteers
- 138 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Advanced Solid Tumor, CNS Tumor
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.
- Conditions
- Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
- Trial name
- NEWEL (NCT05222165)
- Testing
- Infigratinib
- Where
- 10 sites in United States, Canada and 1 more
- Sponsor
- Helsinn Healthcare SA
FGFR2 Amplification, FGFR2 Gene Mutation
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in…
- Conditions
- FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation
- Trial name
- NCT04526106
- Testing
- RLY-4008
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 490 people
- Sponsor
- Elevar Therapeutics