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Gene fusion in FGFR2

FGFR2 fusion or rearrangement

Active trials
37
Recruiting now
17
FDA approvals
3
EU approvals
2
Companies
14

Trials that select patients by FGFR2 fusion or rearrangement or a broader group that includes it, the therapies approved for it, and who is developing what. Seen most often in cholangiocarcinoma.

Added in v3.0. Matches on this page are included in our accuracy checks (about 9 in 10 correct across all pages) but have had fewer checks than the original pages. Every trial shows the words that matched.

Trials as of 2026-10-27. No new trials, status changes or approvals since 2026-10-20. Earlier weeks. Follow this page. .

Active trials by phase
Phase 1: 8 active trials18Phase 1/2: 4 active trials1/24Phase 2: 18 active trials218Phase 2/3: 1 active trials2/31Phase 3: 5 active trials35N/A: 1 active trialsNo phase1
Trials started per year (2026 so far)
2010: 0 trials started20102011: 0 trials started2012: 1 trials started2013: 2 trials started2014: 4 trials started2015: 4 trials started20152016: 2 trials started2017: 5 trials started2018: 6 trials started2019: 9 trials started2020: 14 trials started20202021: 10 trials started2022: 16 trials started162023: 9 trials started2024: 4 trials started2025: 5 trials started2026: 3 trials started32026

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Where we have them, the pivotal trial's results and side effects are shown under each therapy, from the official label. Results from different trials are not directly comparable: patients, earlier treatments and comparators differ.

Results side by side

The pivotal trials behind the approvals below, on one scale. Trials differ in patients, earlier treatment and comparator, so this is a map of the evidence, not a ranking.

Response rates Share of patients whose tumours shrank by at least 30%, with 95% confidence interval where reported.
cholangiocarcinoma
lirafugratinib REFOCUS 46%
futibatinib FOENIX-CCA2 (TAS-120-101) 42%
pemigatinib FIGHT-202 36%
cholangiocarcinoma (intrahepatic)
futibatinib FOENIX-CCA2 (TAS-120-101) 42%
TherapyTumourUnited StatesEuropean Union
futibatinib
EU (EMA), 2023
locally advanced or metastatic, FGFR2 fusion or rearrangement, after >=1 prior line of systemic therapy EU conditional authorisation 04/07/2023. Source
Lytgobifutibatinib page 		cholangiocarcinoma Not approved Approved 2023 conditional

FOENIX-CCA2 (TAS-120-101) single-arm, 103 patients
Response 42%Lasting almost 10 months on average

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma (NCT02052778)
Most common side effects
nail toxicity, musculoskeletal pain, constipation, diarrhoea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, taste changes
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
lirafugratinib
FDA, 2026
previously treated, unresectable locally advanced or metastatic, FGFR2 fusion or other rearrangement FDA approval 23/09/2026; the FDA announcement does not say whether the approval is accelerated. Source
Lyrfigtulirafugratinib page 		cholangiocarcinoma Approved 2026 Not approved

REFOCUS single-arm, 116 without prior FGFR inhibitor
Response 46% (36-55)Lasting 11.8 months

Serious side effects 32%Stopped for side effects 5%Fatal 0.9%

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement cholangiocarcinoma (NCT04526106)
Most common side effects
nail toxicity 89%, hand-foot syndrome 82%, stomatitis 80%, alopecia 66%, dry eye 53%, dry mouth 50%, fatigue 43%, retinal pigment epithelial detachment 38% (116 patients)
Notes
FDA approval summary (2026). FGFR2-selective inhibitor. Warnings: eye toxicity, high phosphate. Side effects: Lyrfigtu US label, section 6 (REFOCUS).
Source
FDA approval summary
pemigatinib
FDA, 2020
previously treated, unresectable locally advanced or metastatic, FGFR2 fusion or other rearrangement FDA accelerated approval 17/04/2020; companion test FoundationOne CDx. Source
EU (EMA), 2021
locally advanced or metastatic, FGFR2 fusion or rearrangement, after >=1 prior line of systemic therapy EU conditional authorisation 26/03/2021. Source
Pemazyrepemigatinib page 		cholangiocarcinoma Approved 2020 accelerated Approved 2021 conditional

In the FDA approval summary

FIGHT-202 single-arm, 107 patients
Response 36% (27-45)Lasting 9.1 months

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement cholangiocarcinoma (NCT02924376)
Most common side effects
high phosphate, alopecia, diarrhoea, nail toxicity, fatigue, taste changes, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite
Notes
FDA approval summary (2020); side effects are those in 20% or more of patients. Eye toxicity and high phosphate need monitoring.
Source
FDA approval summary

In the EU summary (EPAR)

FIGHT-202 single-arm, 108 patients
Response 37%Lasting 8 months on average

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement cholangiocarcinoma (NCT02924376)
Most common side effects
high phosphate, alopecia, diarrhoea, nail toxicity, fatigue, taste changes, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
futibatinib
FDA, 2022
previously treated, unresectable locally advanced or metastatic intrahepatic, FGFR2 fusion or other rearrangement FDA accelerated approval 30/09/2022. Source
Lytgobifutibatinib page 		cholangiocarcinoma (intrahepatic) Approved 2022 accelerated Not approved

FOENIX-CCA2 (TAS-120-101) single-arm, 103 patients
Response 42% (32-52)Lasting 9.7 months

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma (NCT02052778)
Most common side effects
nail toxicity, musculoskeletal pain, constipation, diarrhoea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, taste changes
Notes
FDA approval as reported by ASCO Post (2022); side effects are those in 20% or more of patients.
Source
US approval report
infigratinib
FDA, 2021
previously treated, unresectable locally advanced or metastatic, FGFR2 fusion or other rearrangement Accelerated approval May 2021; withdrawn 16/05/2024 at the sponsor's request (confirmatory trial could not enrol). Source
Truseltiqinfigratinib page 		cholangiocarcinoma Withdrawn approved 2021 Not approved

Companion diagnostic tests

Tests the FDA has approved to select patients for a specific therapy. Other validated tests are often used in practice, especially in Europe.

TestSampleForTumourSince
FoundationOne CDxFoundation Medicine tissue pemigatinib cholangiocarcinoma 2020

Drugs in active trials

Targeted drugs, antibody-drug conjugates and immunotherapies in active trials on this page, approved ones first, then by the furthest phase reached. Chemotherapy and supportive medicines are left out. "Not yet classified" means an early drug known only by its code.

25 of 25 drugs shown

DrugTypeActive trialsFurthest phaseLead sponsors
pemigatinib FDA EUFGFR1-3 FGFR inhibitor 7 Phase 2 Incyte
futibatinib FDA EUFGFR1-4 (covalent) FGFR inhibitor (irreversible) 1 Phase 2 Taiho Pharmaceutical
lirafugratinib FDAFGFR2 FGFR2-selective inhibitor 1 Phase 2 Elevar Therapeutics
erdafitinibFGFR1-4 FGFR inhibitor 10 Phase 3 Johnson & Johnson
tinengotinibFGFR/Aurora/JAK multi-kinase inhibitor (FGFR) 2 Phase 3 TransThera Sciences
HMPL-453FGFR1-3 FGFR inhibitor 1 Phase 2/3 HUTCHMED
pembrolizumabPD-1 anti-PD-1 antibody 1 Phase 3 Johnson & Johnson
durvalumabPD-L1 anti-PD-L1 antibody 3 Phase 2 AstraZeneca
ABSK061FGFR2/3 FGFR2/3-selective inhibitor 1 Phase 2 Abbisko Therapeutics
atezolizumabPD-L1 anti-PD-L1 antibody 1 Phase 2 Academic only
CGT4859 Not yet classified 1 Phase 1/2 Cogent Biosciences
derazantinibFGFR1-3 FGFR inhibitor 1 Phase 2 Academic only
gunagratinibFGFR1-4 FGFR inhibitor 1 Phase 2 Beijing InnoCare Pharma Tech
mirdametinibMEK1/2 MEK inhibitor 1 Phase 1/2 Academic only
tovorafenibRAF (type II) pan-RAF inhibitor 1 Phase 2 Academic only
TYRA-200 Not yet classified 2 Phase 1 Tyra Biosciences
ABSK121 Not yet classified 1 Phase 1 Abbisko Therapeutics
adavosertibWEE1 WEE1 inhibitor 1 Phase 1 AstraZeneca
afatinibEGFR/HER2 EGFR TKI (2nd generation) 1 Phase 1 Academic only
AZD9150 Not yet classified 1 Phase 1 AstraZeneca
enfortumab vedotinNectin-4 Nectin-4 ADC 1 Phase 1 Academic only
fexagratinibFGFR1-3 FGFR inhibitor 1 Phase 1 AstraZeneca
KNT-0916 Not yet classified 1 Phase 1 KinoTeck Therapeutics
olaparibPARP PARP inhibitor 1 Phase 1 AstraZeneca
selumetinibMEK1/2 MEK inhibitor 1 Phase 1 AstraZeneca

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months: the date the main results are due to be collected, according to the sponsor. Results are usually published months later, and these dates often slip.

DueTrialPhaseDrugsSponsor
2026-12 Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in CholangiocarcinomaNCT05948475 · 200 patients Phase 3 tinengotinib, Physician's Choice TransThera Sciences
2026-12 A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic AlterationsNCT06906562 · 40 patients Phase 2 pemigatinib Sameek Roychowdhury
2026-12 Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or RearrangementNCT05727176 · 120 patients Phase 2 futibatinib Taiho Pharmaceutical
2027-03 A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid TumorsNCT06777316 · 110 patients Phase 1/2 CGT4859 Cogent Biosciences
2027-09 A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or RearrangementNCT07359820 · 30 patients Phase 2 lirafugratinib Elevar Therapeutics

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

  1. Johnson & Johnson 6
  2. TransThera Sciences 2
  3. Abbisko Therapeutics 2
  4. 3H (Suzhou) Pharmaceuticals 2
  5. HUTCHMED 1
  6. 3D Medicines 1
  7. Beijing InnoCare Pharma Tech 1
  8. Elevar Therapeutics 1
  9. Incyte 1
  10. Taiho Pharmaceutical 1
  11. Cogent Biosciences 1
  12. AstraZeneca 1
  13. KinoTeck Therapeutics 1
  14. Tyra Biosciences 1

Trials

Matched automatically from registry text, so a few trials may only mention FGFR2 fusion or rearrangement rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

37 of 110 trials shown

  1. Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations

    Not yet recruiting Phase 3 TransThera Sciences Started 2026Primary completion 2029-12 NCT07328919

    tinengotiniboxaliplatinfluorouracilleucovorinirinotecancapecitabine

    The presence of FGFR2 gene fusion/rearrangement or mutation must be confirmed by detection using tumor tissue samples provi…

    Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma

  2. HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

    Recruiting Phase 2/3 HUTCHMED Started 2020Primary completion 2028-06 NCT04353375

    HMPL-453

    … or cytologically confirmed locally advanced unresectable or metastatic ICC patients with FGFR2 fusions/rearrangements/mutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4…

    Advanced Intrahepatic Cholangiocarcinoma, Solid Tumor, Adult

  3. A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

    Recruiting Phase 2 Elevar Therapeutics Started 2026Primary completion 2027-09 NCT07359820

    lirafugratinib FDA

    Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.

    FGFR2 Gene Fusion/Rearrangement, Other Solid Tumors, Adult

  4. Pemigatinib Plus PD-1 Inhibitor With or Without Chemotherapy in FGFR2 Fusion/Rearrangement-Positive Cholangiocarcinoma

    Recruiting Phase 2 Haitao Zhao, MD Started 2026Primary completion 2027-12 NCT07786766

    PemigatinbPD-1 inhibitorsChemotherapy

    Histologically confirmed FGFR2 fusion or rearrangement. 5.

    Biliary Tract Cancer (BTC)

  5. Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma

    Recruiting Phase 2 Ohio State University Comprehensive Cancer Center Started 2026Primary completion 2027-12 NCT07780838

    cisplatindurvalumabgemcitabinepemigatinib FDA EU

    Patients must have tumors classified as having FGFR2 gene fusion/rearrangements or other gain-of function alterations involved in FGFR as detected by any …

    Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma, Locally Advanced Extrahepatic Cholangiocarcinoma, Locally Advanced Gallbladder Carcinoma

  6. Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma

    Not yet recruiting Phase 2 3D Medicines Started 2026Primary completion 2027-12 NCT05039892

    3D185

    …n Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Alterations

    Cholangiocarcinoma,Adult

  7. 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

    Not yet recruiting Phase 2 Incyte Started 2026Primary completion 2031-02 NCT07862998

    pemigatinib FDA EU

    Documented FGFR2 fusion or rearrangement

    Unresectable Cholangiocarcinoma, Advanced/Metastatic Cholangiocarcinoma

  8. A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations

    Recruiting Phase 2 Sameek Roychowdhury Started 2025Primary completion 2026-12 NCT06906562

    pemigatinib FDA EU

    Cohort 1: Pancreatic cancer of any histology with FGFR2 fusion/translocation (n, up to 30) who have progressed on or are intolerant to at least one stan…

    Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8

  9. Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

    Not yet recruiting Phase 2 Eastern Hepatobiliary Surgery Hospital Started 2024Primary completion 2026-08 NCT06530823

    pemigatinib FDA EUdurvalumab

    …d, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;

    Status may be outdated, last updated 2024-07-31Biliary Tract Carcinoma, Cholangiocarcinoma

  10. A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

    Recruiting Phase 1/2 3H (Suzhou) Pharmaceuticals Started 2024Primary completion 2028-06 NCT06378593

    3HP-2827

    A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

    Solid Tumors With FGFR2 Alterations, Adult

  11. Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

    Recruiting Phase 2 Taiho Pharmaceutical Started 2023Primary completion 2026-12 NCT05727176

    futibatinib FDA EU

    Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement

    Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement

  12. A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

    Recruiting Phase 2 Beijing InnoCare Pharma Tech Started 2022Primary completion 2026-05 NCT05678270

    gunagratinib

    FGFR2 fusion /rearrangement as confirmed by the central laboratory.

    Status may be outdated, last updated 2024-02-07Intrahepatic Cholangiocarcinoma (ICC)

  13. Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements

    Active, not recruiting Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2022Primary completion 2025-12 NCT05174650

    atezolizumabderazantinib

    Histologically documented diagnosis of non-resectable iCCA with positively confirmed FGFR2 fusion/rearrangement via NGS-Analysis.

    Intrahepatic Cholangiocarcinoma

  14. A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

    Not yet recruiting Phase 1 3H (Suzhou) Pharmaceuticals Started 2026Primary completion 2028-03 NCT06287918

    3HP-2827

    …-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

    Solid Tumors With FGFR2 Alterations, Adult

  15. A Study of KNT-0916 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

    Recruiting Phase 1 KinoTeck Therapeutics Started 2025Primary completion 2027-09 NCT06800196

    KNT-0916

    Documented FGFR2 gene fusion, mutation, or amplification per testing of blood and/or tumor

    Solid Tumors With FGFR2 Alterations, Adult

  16. Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

    Recruiting Phase 1 Massachusetts General Hospital Started 2024Primary completion 2027-12 NCT06302621

    afatinibpemigatinib FDA EU

    FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion on tumor profiling in …

    Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Cholangiocarcinoma

  17. A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK121-NX in Patients With Advanced Solid Tumors

    Active, not recruiting Phase 1 Abbisko Therapeutics Started 2023Primary completion 2026-03 NCT05627063

    ABSK121-NX

    Intrahepatic Cholangiocarcinoma (iCCA): FGFR2 fusions or rearrangements which containing an intact kinase domain as follows:

    Solid Tumor

  18. Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

    Active, not recruiting Phase 1 Tyra Biosciences Started 2023Primary completion 2027-03 NCT06160752

    Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cyPhase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cyc

    Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

    Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor, Metastatic Cholangiocarcinoma

  19. A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

    Recruiting Phase 3 Johnson & Johnson Started 2025Primary completion 2028-04 NCT06919965

    erdafitinibMitomycin Cgemcitabine

    Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determin…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

  20. A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

    Recruiting Phase 3 Johnson & Johnson Started 2024Primary completion 2028-06 NCT06319820

    erdafitinibgemcitabineMMC

    Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determi…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

  21. Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Active, not recruiting Phase 3 TransThera Sciences Started 2023Primary completion 2026-12 NCT05948475

    tinengotinibPhysician's Choice

    Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

    Broad match: FGFR alteration (unspecified)Cholangiocarcinoma

  22. 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

    Active, not recruiting Phase 3 Johnson & Johnson Started 2018Primary completion 2024-04 NCT03390504

    erdafitinibVinfluninedocetaxelpembrolizumab

    …ticipants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

    Broad match: FGFR alteration (unspecified)Urothelial Cancer

  23. Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)

    Not yet recruiting Phase 2 Nationwide Children's Hospital Starts 2027Primary completion 2030-02 NCT07206849

    tovorafenib

    …included in Stratum A (KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.

    Broad match: FGFR alteration (unspecified)High Grade Glioma (HGG) of the Brain With BRAF Aberration, High Grade Glioma (III or IV), Diffuse Intrinsic Pontine Glioma, High Grade Glioma

  24. A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

    Active, not recruiting Phase 1/2 Cogent Biosciences Started 2025Primary completion 2027-03 NCT06777316

    CGT4859

    …cally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.

    Broad match: FGFR alteration (unspecified)Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement

  25. A Phase 2 Clinical Study of ABSK061 and ABSK043

    Recruiting Phase 2 Abbisko Therapeutics Started 2024Primary completion 2029-11 NCT06632262

    ABSK061CAPOX

    …vious test report confirming the presence of a specific FGFR3 mutation or overexpression, FGFR2/3 fusion in tumor tissue or blood based on central laboratory test or previous test reports.

    Broad match: FGFR alteration (unspecified)HER2-Gastric/Gastroesophageal Junction Cancer, Urothelial Carcinoma, Non-Small Cell Lung Cancer, Solid Tumors

  26. Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

    Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024Primary completion 2026-07 NCT06551896

    pemigatinib FDA EU

    Pemigatinib and Immune Checkpoint Inhibitor Treated FGFR1/2/3 Alteration Advanced Solid Tumor

    Broad match: FGFR alteration (unspecified)Status may be outdated, last updated 2024-08-13Urothelial Carcinoma, Breast Neoplasms, Lung Cancer, Gastric Cancer

  27. Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations

    Recruiting Phase 2 Spanish Oncology Genito-Urinary Group Started 2023Primary completion 2026-07 NCT06511648

    erdafitinib

    Presence of a selected FGFR alteration on analysis of tumour biopsy

    Broad match: FGFR alteration (unspecified)Muscle-invasive Bladder Cancer

  28. Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

    Active, not recruiting Phase 1/2 Johnson & Johnson Started 2022Primary completion 2028-03 NCT05316155

    erdafitinib

    For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to th…

    Broad match: FGFR alteration (unspecified)Non-Muscle Invasive Bladder Neoplasms

  29. Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2022Primary completion 2024-12 NCT05651672

    pemigatinib FDA EU

    With histologically confirmed FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement

    Broad match: FGFR alteration (unspecified)Status may be outdated, last updated 2022-12-15Gastrointestinal Cancer

  30. SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma

    Recruiting Phase 1/2 St. Jude Children's Research Hospital Started 2021Primary completion 2031-06 NCT04923126

    mirdametinib

    BRAF fused or rearranged, FGFR1/2/3 aberration, NF1, NF2, PTPN11, SOS1, RAF1 mutations, MYB or MYBL1 fused or rearranged, etc.) or occur…

    Broad match: FGFR alteration (unspecified)Low-Grade Glioma, Recurrent Low-Grade Glioma, Progressive Low-Grade Glioma

  31. Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2022-06 NCT06351371

    erdafitinib

    Patients must have FGFR mutation or fusion as determined via the MATCH Master Protocol

    Broad match: FGFR alteration (unspecified)Malignant Solid Neoplasm

  32. 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 Phase 2 National Cancer Institute (NCI) Started 2018Primary completion 2023-09 NCT03210714

    erdafitinib

    … or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

    Broad match: FGFR alteration (unspecified)Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma

  33. An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

    Active, not recruiting Phase 2 Johnson & Johnson Started 2015Primary completion 2022-09 NCT02365597

    erdafitinibmidazolammetformin

    …NJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

    Broad match: FGFR alteration (unspecified)Urothelial Cancer

  34. A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer

    Active, not recruiting Phase 1 Johnson & Johnson Started 2023Primary completion 2025-03 NCT05567185

    erdafitinib

    At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine s…

    Broad match: FGFR alteration (unspecified)Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor

  35. Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

    Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2022Primary completion 2026-12 NCT04963153

    enfortumab vedotinerdafitinib

    …ith Enfortumab Vedotin Following Prior Therapies for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

    Broad match: FGFR alteration (unspecified)Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma, Locally Advanced Urethral Urothelial Carcinoma

  36. Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2016Primary completion 2020-03 NCT02546661

    fexagratinibdurvalumabolaparibadavosertibVistusertibAZD9150selumetinib

    Confirmation of FGFR3 mutation or FGFR fusion

    Broad match: FGFR alteration (unspecified)Muscle Invasive Bladder Cancer

  37. Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients

    Recruiting No phase Royal Marsden NHS Foundation Trust Started 2025Primary completion 2026-12 NCT07673861

    Identified targetable mutation (IDH1 mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR deficiency \[dMMR\]), AND

    Broad match: FGFR2 fusion or rearrangementNon Small Cell Lung Cancer, Gastrointestinal Stromal Tumor (GIST), Colorectal Cancer, Biliary Tract Cancer