FGFR inhibitor · small molecule

infigratinib

0 active trials across 4 of our biomarkers, targeting FGFR1-3. Not approved for any biomarker on marked.bio yet.

Also known as BGJ398, NVP-BGJ398, Truseltiq.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

Therapy	Biomarker	Tumour	United States	European Union
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unresectable locally advanced or metastatic, FGFR2 fusion or other rearrangement Accelerated approval May 2021; withdrawn 16/05/2024 at the sponsor's request (confirmatory trial could not enrol). Source Truseltiq	FGFR2 fusion or rearrangement	cholangiocarcinoma	Withdrawn approved 2021	Not approved

Biomarkers

Biomarker	All trials	Furthest active phase
BRAF V600E	1	–
FGFR2 fusion or rearrangement	11	–
FGFR3 alteration (mutation or fusion)	13	–
PIK3CA activating mutation	1	–

Trials

0 of 17 trials shown

Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations

Terminated Phase 3 QED Therapeutics, a BridgeBio Started 2020 NCT04197986

infigratinib

…histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations.

FGFR3 alteration (mutation or fusion)Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Terminated Phase 3 QED Therapeutics, a BridgeBio Started 2019 NCT03773302

infigratinibgemcitabinecisplatin

…n of local laboratory or central laboratory determination of a known or likely activating FGFR2 fusion/rearrangement from a sample collected before randomization

FGFR2 fusion or rearrangementAdvanced Cholangiocarcinoma, FGFR2 Gene Mutation
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations

Withdrawn Phase 1/2 Helsinn Healthcare Started 2021 NCT05222165

infigratinib

…jects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementAdvanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations

Unknown status Phase 2 LianBio Started 2020 NCT05019794

infigratinib

… of standard therapy on medical grounds.(3) Previous documented proof of FGFR1, FGFR2 ,or FGFR3 fusions/rearrangements and activating mutations (FISH/NGS/PCR results could be accepted) presente…

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementGastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

Completed Phase 2 Sameek Roychowdhury Started 2020 NCT04233567

infigratinib

… central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or activating mutations

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementAdvanced Malignant Solid Neoplasm, Cholangiocarcinoma, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer

Terminated Phase 2 University of Chicago Started 2018 NCT02706691

infigratinib

FGFR3 somatic mutations, FGFR3 translocations, FGFR3 amplification

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementFGFR Gene Amplification, FGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation
LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma

Completed Phase 2 Pfizer Started 2014 NCT02159066

encorafenib FDA EUbinimetinib FDA EUribociclibinfigratinibbuparlisibcapmatinib

Documented evidence of BRAF V600 mutation.

BRAF V600EMelanoma
BGJ398 for Patients With Tumors With FGFR Genetic Alterations

Terminated Phase 2 Novartis Started 2014 NCT02160041

infigratinib

Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration.

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementSolid Tumor, Hematologic Malignancies
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma

Terminated Phase 2 QED Therapeutics, a BridgeBio Started 2014 NCT02150967

infigratinib

… Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementAdvanced Cholangiocarcinoma, FGFR2 Gene Mutation
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification

Withdrawn Phase 1 M.D. Anderson Cancer Center Started 2023 NCT05510427

infigratinibatezolizumabbevacizumab

Has FGFR2 fusion in tumor tissue.

FGFR2 fusion or rearrangementCholangiocarcinoma, Liver Cancer
Phase I BLASST-3 Trial

Withdrawn Phase 1 Guru P. Sonpavde Started 2021 NCT04972253

infigratinib

Any FGFR3/2 gene fusion (Availability of baseline archival tumor tissue for identification of FGFR3/2 alterations…

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementBladder Transitional Cell Carcinoma, Bladder Cancer, Fibroblast Growth Factor Receptor
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

Terminated Phase 1 Jennifer Lee Caswell-Jin Started 2020 NCT04504331

infigratinibTamoxifenOmnipaque 350Iopamidol

…f Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementBreast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
Ph Ib/BGJ398/Cervix and Other Solid Tumors

Withdrawn Phase 1 The University of Texas Health Science Center at San Antonio Started 2015 NCT02312804

infigratinibcarboplatinpaclitaxel

Confirmation of FGF/FGFR aberration is not required.

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementCancer of Cervix, Tumors
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Completed Phase 1 Novartis Started 2013 NCT01928459

infigratinibalpelisib FDA EU

Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alter…

PIK3CA activating mutationAdvanced Solid Tumors, Metastatic Solid Tumors
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Completed Phase 1 Novartis Started 2009 NCT01004224

infigratinib

…ically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists

FGFR3 alteration (mutation or fusion)Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification, Bladder Cancer With FGFR3 Mutation or Fusion, Advanced Solid Tumors With FGFR1 Amplication
Infigratinib in Recurrent High-Grade Glioma Patients

Terminated Early Phase 1 Nader Sanai Started 2020 NCT04424966

infigratinib

Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR.

FGFR3 alteration (mutation or fusion)Glioma, Glioblastoma, GBM
BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

Completed No phase Memorial Sloan Kettering Cancer Center Started 2016 NCT02657486

infigratinib

Documentation of activating FGFR3 mutation or gene fusion on an assay performed in a CLIA-certified laboratory.

FGFR3 alteration (mutation or fusion)Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma