Therapy Detail

Therapy Name BGJ398
Synonym
Therapy Description

Infigratinib (BGJ398) is pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (PMID: 31109923).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
BGJ398 Infigratinib FGFR Inhibitor (Pan) 18 Infigratinib (BGJ398) is pan-FGFR inhibitor, which inhibits tumor angiogenesis and tumor cell proliferation (PMID: 31109923).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 mutant cholangiocarcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, a patient with cholangiocarcinoma harboring an FGFR2 mutation demonstrated a decreased tumor burden when treated with BGJ398 (PMID: 27870574). 27870574
FGFR2-ZMYM4 FGFR2 V565F FGFR2 K660M FGFR2 E566A FGFR2 N550H FGFR2 N550K intrahepatic cholangiocarcinoma resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma harboring an FGFR2-ZMYM4 fusion developed progressive disease after initial response to Infigratinib (BGJ398) for 5.6 months and FGFR2 V565F, K660M E566A, N550H, and N550K mutations were identified in the post-progression cell-free DNA (PMID: 31109923). 31109923
FGFR1 positive synovial sarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, synovial sarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
FGFR3 S249C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR3 S249C in culture (PMID: 23786770). 23786770
FGFR2 fusion FGFR2 N550H intrahepatic cholangiocarcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550H had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR3 V555L transitional cell carcinoma resistant BGJ398 Case Reports/Case Series Actionable In a clinical study, two patients with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555L (also corresponds to V443L) (PMID: 29848605). 29848605
FGFR1 amp synovial sarcoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited survival of FGFR1 amplified synovial sarcoma cells in culture (PMID: 27535980). 27535980
FGFR2 amp breast cancer sensitive BGJ398 Phase I Actionable In a Phase I trial, a breast cancer patient harboring an FGFR2 amplification demonstrated stable disease when treated with BGJ398 (PMID: 27870574). 27870574
FGFR2 K660N Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 K660N in culture and inhibited tumor growth in xenograft models (PMID: 23786770). 23786770
FGFR2 amp FGFR2 over exp stomach cancer sensitive BGJ398 Preclinical - Pdx Actionable In a preclinical study, BGJ398 decreased Myc expression and inhibited tumor growth in patient-derived xenograft (PDX) models of gastric cancer with FGFR2 amplification and over expression (PMID: 27401245). 27401245
FGFR2 - TACC3 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 - TACC3 (PMID: 26048680). 26048680
FGFR3-TACC3 lung adenocarcinoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited growth and FGFR3 phosphorylation in cells expressing FGFR3-TACC3 fusion in culture (PMID: 25294908). 25294908
FGFR2 W290C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 W290C in culture and inhibited tumor growth in xenograft models (PMID: 23786770). 23786770
FGFR3 R248C Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR3 R248C in culture (PMID: 23786770). 23786770
FGFR3 K650E Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 K650E demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2 fusion FGFR2 K715R intrahepatic cholangiocarcinoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K715R were sensitive to treatment as demonstrated by decreased cell viability and decreased activation of downstream signaling, in in vitro assays (PMID: 31109923). 31109923
FGFR2 S267_D273dup Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 S267_D273dup (PMID: 26048680). 26048680
FGFR3 S131L head and neck squamous cell carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, a head and neck squamous cell carcinoma cell line expressing FGFR3 S131L demonstrated decreased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 in culture (PMID: 27053219). 27053219
FGFR2 fusion FGFR2 H683L intrahepatic cholangiocarcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 H683L had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR2-AHCYL1 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, treatment with BGJ398 prevented transformation of cells expressing FGFR2-AHCYL1 in culture (PMID: 24122810). 24122810
FGFR3 mutant Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, tumor cell lines with FGFR3 mutations demonstrated sensitivity to BGJ398 in culture (PMID: 23002168). 23002168
FGFR2-ZMYM4 intrahepatic cholangiocarcinoma sensitive BGJ398 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-ZMYM4 fusion responded to Infigratinib (BGJ398) for 5.6 months before progressing due to acquired FGFR2 V565F, K660M, E566A, N550H, and N550K mutations, detected in cell-free DNA (PMID: 31109923). 31109923
FGFR1 amp breast cancer sensitive BGJ398 Phase I Actionable In a Phase I trial, 28% (9/32) of breast cancer patients harboring FGFR1 amplification demonstrated stable disease when treated with BGJ398 (PMID: 27870574). 27870574
FGFR2 fusion FGFR2 V564F cholangiocarcinoma predicted - resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, FGFR2 V564F was identified in the cell-free DNA of 3 cholangiocarcinoma patients harboring FGFR2 fusion after the patients progressed while on Infigratinib (BGJ398) treatment (PMID: 28034880). 28034880
FGFR3 mutant bladder urothelial carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, patients with bladder urothelial carcinoma harboring an FGFR3 mutation demonstrated a disease control rate of 75% (6/8) when treated with BGJ398, including 3 patients with a partial response and 3 with stable disease (PMID: 27870574; NCT01004224). 27870574
FGFR3 N540K Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 N540K were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2 E565A FGFR2 K659M FGFR2 N549H FGFR2 N549K FGFR2 V564F FGFR2-ZMYM4 cholangiocarcinoma predicted - resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, FGFR2 mutations E565A, K659M, N549H, N549K and V564F were identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-ZMYM4 fusion after the patient progressed while on Infigratinib (BGJ398) treatment (PMID: 28034880). 28034880
FGFR1 amp KRAS G12V non-small cell lung carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression of KRAS G12V in FGFR1-amplified non-small cell lung carcinoma cells resulted in decreased response to BGJ398 in culture (PMID: 28630215). 28630215
FGFR2 amp colon cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 reduced Myc expression, induced cell-cycle arrest, and inhibited growth of a colon cancer cell line with FGFR2 amplification in culture (PMID: 27401245). 27401245
FGFR2 fusion FGFR2 K660M intrahepatic cholangiocarcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 K660M were resistant to treatment as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR3-BAIAP2L1 urinary bladder cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a bladder cancer cell line harboring FGFR3-BAIAP2L1 in culture (PMID: 25589496). 25589496
FGFR2 K660E Advanced Solid Tumor sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited growth of transformed cells expressing FGFR2 K660E in culture (PMID: 23786770). 23786770
FGFR2-SORBS1 FGFR2 K660M FGFR2 K715R intrahepatic cholangiocarcinoma resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma harboring an FGFR2-SORBS1 fusion developed progressive disease after initial response to Infigratinib (BGJ398) for 12.6 months and FGFR2 K660M and FGFR2 K715R were identified in the post-progression cell-free DNA (PMID: 31109923). 31109923
FGFR1 over exp head and neck squamous cell carcinoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited cell growth and induced apoptosis in HNSCC cells over expressing Fgfr1 in culture and in xenograft models (PMID: 26015511). 26015511
FGFR3 fusion transitional cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517)). detail...
FGFR2 fusion cholangiocarcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, two patients with cholangiocarcinoma harboring FGFR2 fusions demonstrated a decreased tumor burden when treated with BGJ398 (PMID: 27870574). 27870574
FGFR3 amp urinary system cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 decreased Myc expression, induced cell cycle arrest, and inhibited growth of a urinary tract cancer cell line harboring FGFR3 amplification in culture (PMID: 27401245). 27401245
FGR2 E565A FGFR2 K641R FGFR2 L617V FGFR2 N549H FGFR2 V564F FGFR2-OPTN cholangiocarcinoma predicted - resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, FGFR2 mutations E565A, K641R, L617V, N549H and V564F were identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-OPTN fusion after the patient progressed while on Infigratinib (BGJ398) treatment (PMID: 28034880). 28034880
FGFR1 positive leiomyosarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, leiomyosarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
FGFR3 amp Advanced Solid Tumor predicted - sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 demonstrated safety and preliminary efficacy in patients with select solid tumors harboring FGFR alterations (Cancer Res October 1, 2014 74:CT326). detail...
FGFR2-BICC1 Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, treatment with BGJ398 prevented transformation of cells expressing FGFR2-BICC1 in culture (PMID: 24122810). 24122810
FGFR2 mutant endometrial cancer sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited the growth of FGFR2-mutated endometrial cancer cells in vitro and in xenograft models (PMID: 23443805). 23443805
FGFR2-NRAP intrahepatic cholangiocarcinoma sensitive BGJ398 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-NRAP fusion responded to Infigratinib (BGJ398) for 7.1 months before progressing (PMID: 31109923). 31109923
FGFR2 W290_I291delinsC Advanced Solid Tumor sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 prevented oncogenic transformation of cells expressing FGFR2 W290_I291delinsC (PMID: 26048680). 26048680
FGFR3 mutant transitional cell carcinoma sensitive BGJ398 Clinical Study Actionable In a clinical study, BGJ398 treatment led to 25.4% (17/67) confirmed responses and a disease control rate of 64% (43/67), which included complete responses, partial responses, and stable disease, and resulted in a median progression-free survival of 3.75 months and a median overall survival of 7.75 months (PMID: 29848605). 29848605
FGFR3 mutant transitional cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, BGJ398 treatment resulted in complete response in 4% (1/25) and partial response in 32% (8/25) of urothelial carcinoma patients harboring FGFR3 mutations or fusions (J Clin Oncol 34, 2016 (suppl; abstr 4517); NCT01004224). detail...
FGFR3 S249C urinary system cancer sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 decreased Myc expression, induced cell cycle arrest, and inhibited growth of a urinary tract cancer cell line harboring FGFR3 S249C in culture (PMID: 27401245). 27401245
FGFR1 amp MET amp lung squamous cell carcinoma predicted - resistant BGJ398 Phase I Actionable In a Phase I trial, MET amplification was detected in a squamous cell lung cancer patient harboring FGFR1 amplification whose disease relapsed after 17 months of BGJ398 treatment, supporting a role of MET amplification in drug resistance in FGFR1-amplified lung cancer (PMID: 28630215). 28630215
FGFR2-TNS1 triple-receptor negative breast cancer sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, triple-receptor negative breast cancer xenograft models harboring FGFR2-TNS1 demonstrated tumor regression when treated with BGJ398 (PMID: 29203461). 29203461
FGFR3 V555M Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 V555M were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR1 amp lung squamous cell carcinoma sensitive BGJ398 Phase I Actionable In a Phase I trial, patients with lung squamous cell carcinoma harboring an FGFR1 amplification demonstrated a disease control rate of 50% (18/36) when treated with BGJ398, resulting in 14 patients with stable disease and 4 patients with a partial response (PMID: 27870574). 27870574
FGFR1 amp NRAS over exp non-small cell lung carcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression of Nras in FGFR1-amplified non-small cell lung carcinoma cells resulted in decreased response to BGJ398 in culture (PMID: 28630215). 28630215
FGFR2 fusion FGFR2 V565F intrahepatic cholangiocarcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 V565F were resistant to treatment as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR3 D764H head and neck squamous cell carcinoma no benefit BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a head and neck squamous cell carcinoma cell line expressing FGFR3 D764H in culture, however, cells expressing FGFR3 D764H did not demonstrate increased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 (PMID: 27053219). 27053219
FGFR2 amp myxoid liposarcoma sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 increased apoptosis, and inhibited cell proliferation and migration of myxoid liposarcoma cell lines harboring FGFR2 amplification in culture (PMID: 26036639). 26036639
FGFR1 over exp uterus leiomyosarcoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, PD173074 inhibited survival of FGFR1 over expressing uterus leiomyosarcoma cells in culture (PMID: 27535980). 27535980
FGFR3 over exp urinary bladder cancer sensitive BGJ398 Preclinical - Pdx Actionable In a preclinical study, treatment with BGJ398 led to improved progression-free survival in a patient-derived xenograft (PDX) model of bladder cancer with FGFR3 over expression (PMID: 26270481). 26270481
FGFR3 L608V FGFR3 V555M transitional cell carcinoma resistant BGJ398 Case Reports/Case Series Actionable In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) and FGFR3 L608V (also corresponds to L496V) (PMID: 29848605). 29848605
FGFR3 V555M transitional cell carcinoma resistant BGJ398 Case Reports/Case Series Actionable In a clinical study, a patient with metastatic urothelial carcinoma progressed while being treated with BGJ398 and subsequent cell-free DNA testing revealed FGFR3 V555M (also corresponds to V443M) (PMID: 29848605). 29848605
FGFR2 fusion FGFR2 L618V intrahepatic cholangiocarcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 L618V were resistant to treatment as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR3 D788N head and neck squamous cell carcinoma no benefit BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited proliferation of a head and neck squamous cell carcinoma cell line expressing FGFR3 D788N in culture, however, cells expressing FGFR3 D788N did not demonstrate increased sensitivity to BGJ398 compared to cells expressing wild-type FGFR3 (PMID: 27053219). 27053219
FGFR3 V555L Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 V555L demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2 F276C intrahepatic cholangiocarcinoma predicted - sensitive BGJ398 Phase I Actionable In a Phase II trial, BGJ398 treatment resulted in partial response after 2 month of therapy and maintained the response for 4 months in a patient with advanced intrahepatic cholangiocarcinoma harboring a FGFR2 F276C mutation, which is consistent with inhibition of Erk signaling in cholangiocarcinoma cells expressing FGFR2 F274C in culture (JCO Precis Oncol 2017:1, 1-13; NCT02150967). detail...
FGFR3-TACC3 malignant glioma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BJG398 inhibited Fgfr3 kinase activity in transformed astrocytes expressing the FGFR3-TACC3 fusion in culture (PMID: 22837387). 22837387
FGFR3 L608V Advanced Solid Tumor decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 L608V demonstrated reduced sensitivity to BGJ398 in culture (PMID: 28034880). 28034880
FGFR1 amp NRAS amp non-small cell lung carcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, amplification of NRAS was identified in a non-small cell lung cancer cell line harboring FGFR1 amplification that acquired resistance to BGJ398 in culture (PMID: 28630215). 28630215
FGFR2 V564F Advanced Solid Tumor resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR2 V564F were resistant to BGJ398 in culture (PMID: 28034880). 28034880
FGFR2-FAM76A ovarian cancer sensitive BGJ398 Preclinical - Patient cell culture Actionable In a preclincal study, BGJ398 demonstrated enhanced inhibition of the survival in patient-derived ovarian cancer cells harboring FGFR2 - FAM76A in culture (PMID: 24563622). 24563622
FGFR1 amp MET over exp lung small cell carcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, overexpression and activation of Met was identified in a small cell lung cancer cell line harboring FGFR1 amplification that acquired resistance to BGJ398 in culture (PMID: 28630215). 28630215
BRCA1 loss FGFR2-DNM3 triple-receptor negative breast cancer predicted - sensitive BGJ398 Preclinical - Cell line xenograft Actionable In a preclinical study, BRCA1-deficient triple-receptor negative breast cancer xenograft models harboring FGFR2-DNM3 were sensitive to treatment with BGJ398, demonstrating tumor regression, however, after 43 days on average, three out of six models developed resistance (PMID: 29203461). 29203461
FGFR1-TACC1 malignant glioma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BJG398 inhibited Fgfr1 kinase activity and cell growth in transformed cells expressing the FGFR1-TACC1 fusion in culture (PMID: 22837387). 22837387
FGFR2 V564F FGFR2-BICC1 cholangiocarcinoma predicted - resistant BGJ398 Case Reports/Case Series Actionable In a clinical case study, FGFR2 V564F was identified in the cell-free DNA of a cholangiocarcinoma patient harboring FGFR2-BICC1 fusion after the patient progressed while on Infigratinib (BGJ398) treatment (PMID: 28034880). 28034880
FGFR1 positive uterus leiomyosarcoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, uterine leiomyosarcoma cells with moderate Fgfr1 expression level demonstrated decreased response to BGJ398 in culture (PMID: 27535980). 27535980
FGFR2 fusion FGFR2 N550K intrahepatic cholangiocarcinoma resistant BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 N550K were resistant to treatment as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR2-SORBS1 intrahepatic cholangiocarcinoma sensitive BGJ398 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-SORBS1 fusion responded to Infigratinib (BGJ398) for 12.6 months before progressing due to acquired FGFR2 K660M and K175R mutations, detected in cell-free DNA (PMID: 31109923). 31109923
FGFR2 fusion FGFR2 E566A intrahepatic cholangiocarcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 E566A had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
Unknown unknown alveolar rhabdomyosarcoma not applicable BGJ398 Preclinical - Pdx Actionable In a preclinical study, BGJ398 resulted in antitumor activity in an alveolar rhabdomyosarcoma patient derived xenograft model (PMID: 24687871). 24687871
FGFR2 amp stomach cancer sensitive BGJ398 Preclinical Actionable In a preclinical study, BGJ398 inhibited proliferation of gastric cancer cell lines harboring FGFR2 amplification in culture (PMID: 26036639). 26036639
FGFR2 fusion FGFR2 M538I intrahepatic cholangiocarcinoma decreased response BGJ398 Preclinical - Cell culture Actionable In a preclinical study, Infigratinib (BGJ398) treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 M538I had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR1 amp non-small cell lung carcinoma sensitive BGJ398 Preclinical - Cell culture Actionable In a preclinical study, BGJ398 inhibited Erk signaling and growth of FGFR1-amplified non-small cell lung carcinoma cells in culture (PMID: 28630215). 28630215
Clinical Trial Phase Therapies Title Recruitment Status
NCT02312804 Phase I Paclitaxel Carboplatin BGJ398 Ph Ib/BGJ398/Cervix and Other Solid Tumors Withdrawn
NCT02706691 Phase II BGJ398 Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer Terminated
NCT02160041 Phase II BGJ398 BGJ398 for Patients With Tumors With FGFR Genetic Alterations Completed
NCT02150967 Phase II BGJ398 A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma Recruiting
NCT03773302 Phase III Cisplatin + Gemcitabine BGJ398 Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Recruiting
NCT01004224 Phase I BGJ398 A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies Completed
NCT02657486 Phase 0 BGJ398 BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder Active, not recruiting
NCT01975701 Phase II BGJ398 A Phase 2 Study of BGJ398 in Patients With Recurrent GBM Completed