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Therapy Name Debio 1347
Synonyms
Therapy Description

Debio 1347 inhibits FGFR-1, -2, and -3, resulting in decreased downstream signaling, and potentially leading to reduced tumor cell proliferation and angiogenesis, and increased cell death in FGFR-overexpressing tumor cells (NCI Drug Dictionary).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Debio 1347 CH5183284|FF284|debiopharm 1347 FGFR1 Inhibitor 23 FGFR2 Inhibitor 16 FGFR3 Inhibitor 12 Debio 1347 inhibits FGFR-1, -2, and -3, resulting in decreased downstream signaling, and potentially leading to reduced tumor cell proliferation and angiogenesis, and increased cell death in FGFR-overexpressing tumor cells (PMID: 30745300).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 S249C urinary bladder cancer sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited proliferation of bladder cancer cells harboring FGFR3 S249C in culture and inhibited tumor growth in FGFR3 S249C-positive bladder cancer cell line xenograft models (PMID: 25169980). 25169980
FGFR1 amp Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 fusion FGFR2 L618V intrahepatic cholangiocarcinoma resistant Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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 K650E Advanced Solid Tumor sensitive Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 inhibited proliferation of transformed cells over expressing FGFR3 K650E in culture (PMID: 28034880). 28034880
FGFR2 fusion FGFR2 K660M intrahepatic cholangiocarcinoma resistant Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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 F386L myeloid neoplasm sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 F386L in culture (PMID: 25169980). 25169980
FGFR1 mutant Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR3 K650E myeloid neoplasm sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 K650E in culture (PMID: 25169980). 25169980
FGFR2 V564F Advanced Solid Tumor sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited proliferation of transformed cells over expressing FGFR2 V564F in culture and inhibited tumor growth in cell line xenograft models (PMID: 25169980). 25169980
FGFR2 - INA FGFR2 M538I FGFR2 N550H FGFR2 N550T FGFR2 L618V FGFR2 H683L intrahepatic cholangiocarcinoma resistant Debio 1347 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma harboring an FGFR2-INA fusion developed progressive disease after initial response to Debio 1347 for 11.4 months and FGFR2 H683L, L618V, N550H, N550T, M538I mutations were identified post-progression (PMID: 31109923). 31109923
FGFR2 mutant Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR1 amp lung squamous cell carcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 26.7% reduction of tumor size and 100% decrease of DUSP6 score in a patient with lung squamous cell carcinoma harboring FGFR1 amplification (PMID: 30745300; NCT01948297). 30745300
FGFR2 amp uterine cancer predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 3.9% change of tumor size and 60% decrease of DUSP6 score in a patient with uterine cancer harboring FGFR2 amplification (PMID: 30745300; NCT01948297). 30745300
FGFR2 I288_E295delinsT intrahepatic cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a clinical case study, Debio1347 treatment in an intrahepatic cholangiocarcinoma patient harboring FGFR2 I288_E395delinsT led to a partial response, with a 50% decrease in tumor burden, and ongoing response 24 months post-treatment (PMID: 33926920). 33926920
FGFR2 amp stomach carcinoma sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited tumor growth in cell line xenograft models of FGFR2 amplified gastric carcinoma (PMID: 26438159). 26438159
FGFR3 amp Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 H167_N173del FGFR2 L618F intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, co-expression of FGFR2 H167_N173del and FGFR2 L618F an intrahepatic cholangiocarcinoma cell line led to a reduced response to Debio 1347 treatment compared to cells expressing wild-type FGFR2 in culture (PMID: 33926920). 33926920
FGFR3 Y373C myeloid neoplasm sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of myeloma cell lines harboring FGFR3 Y373C in culture (PMID: 25169980). 25169980
FGFR1 amp lung small cell carcinoma sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of small cell lung cancer cell lines harboring FGFR1 amplification in culture (PMID: 25169980). 25169980
FGFR2 V564I Advanced Solid Tumor resistant Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 did not inhibit Fgfr2 phosphorylation in transformed cells over expressing FGFR2 V564I in culture (PMID: 25169980). 25169980
FGFR2 fusion FGFR2 M538I intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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
FGFR2 fusion FGFR1 amp colon cancer predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a partial response with 49.5% reduction of tumor size and 66% decrease of DUSP6 score in a patient with colon cancer harboring FGFR1 amplification and FGFR2 fusion (PMID: 30745300; NCT01948297). 30745300
FGFR2 fusion FGFR2 K715R intrahepatic cholangiocarcinoma sensitive Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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 H167_N173del marginal zone B-cell lymphoma predicted - sensitive Debio 1347 Preclinical - Cell culture Actionable In a clinical case study, Debio 1347 treatment in a marginal zone lymphoma patient harboring FGFR2 H167_N173del, who had previously been treated with several lines of therapy, led to a partial response, a 36% decrease in tumor burden associated with lymphadenopathy and lung and liver lesions at 16 weeks, and patient continued to respond 7 months after treatment (PMID: 33926920). 33926920
FGFR2 S252W endometrial cancer sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring an FGFR2 S252W mutation in culture and inhibited tumor growth in FGFR2 S252W-positive endometrial cancer cell line xenograft models (PMID: 25169980). 25169980
FGFR2 act mut Advanced Solid Tumor sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR2 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). detail...
FGFR2 fusion FGFR2 V565F intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 treatment of intrahepatic cholangiocarcinoma cells with an FGFR2 fusion in context with FGFR2 V565F had weakened sensitivity, as demonstrated by cell viability and downstream signaling assays (PMID: 31109923). 31109923
FGFR2 H167_N173del FGFR2 L617F intrahepatic cholangiocarcinoma predicted - resistant Debio 1347 Case Reports/Case Series Actionable In a clinical study, a patient with intrahepatic cholangiocarcinoma harboring FGFR2 H167_N173del developed resistance to Debio 1347 treatment after initial response, FGFR2 L617F was identified as an acquired mutation at disease progression (J Clin Oncol 38, 2020 (suppl 4; abstr 567)). detail...
FGFR1 act mut Advanced Solid Tumor sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR1 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). detail...
FGFR2 fusion FGFR2 E566A intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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
FGFR2 H167_N173del intrahepatic cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment led to a tumor reduction of 51% and a progression-free survival of 13 mo in an intrahepatic cholangiocarcinoma patient harboring FGFR2 H167_N173del, and led to inhibition of growth in an intrahepatic cholangiocarcinoma cell line expressing FGFR2 H167_N173del in culture, demonstrating decreased phosphorylation of Frs2 and Erk1/2 (PMID: 33926920; NCT01948297). 33926920
FGFR2 H167_N173del intrahepatic cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a clinical study, Debio 1347 treatment resulted in durable partial response of 11 months in 2 patients with intrahepatic cholangiocarcinoma harboring FGFR2 H167_N173del (J Clin Oncol 38, 2020 (suppl 4; abstr 567)). detail...
FGFR2 - ROCK1 cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in stable disease in a patient with cholangiocarcinoma harboring FGFR2-ROCK1 (PMID: 30745300; NCT01948297). 30745300
FGFR2 fusion FGFR2 N550K intrahepatic cholangiocarcinoma resistant Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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 - DDX21 cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in stable disease in a patient with cholangiocarcinoma harboring FGFR2-DDX21 (PMID: 30745300; NCT01948297). 30745300
FGFR2 - INA colon cancer predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a partial response in 2 patient with colon cancer harboring FGFR2-INA (PMID: 30745300; NCT01948297). 30745300
FGFR2 - INA intrahepatic cholangiocarcinoma sensitive Debio 1347 Case Reports/Case Series Actionable In a clinical case study, a patient with intrahepatic cholangiocarcinoma, harboring an FGFR2-INA fusion responded to Debio 1347 for 11.4 months before progressing due to acquired FGFR2 H683L, L618V, N550H, N550T, and M538I mutations (PMID: 31109923). 31109923
FGFR2 N549K endometrial cancer sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring FGFR2 N549K mutation in culture (PMID: 25169980). 25169980
FGFR2 fusion FGFR2 H683L intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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
FGFR1 amp lung non-small cell carcinoma sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of non-small cell lung cancer cell lines harboring FGFR1 amplification in culture (PMID: 25169980). 25169980
FGFR2 amp colorectal cancer sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of colorectal cancer cell lines harboring FGFR2 amplification in culture (PMID: 25169980). 25169980
FGFR2 amp stomach cancer sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited proliferation of FGFR-amplified gastric cancer cells in culture and inhibited tumor growth in cell line xenograft models of gastric cancer harboring FGFR2 amplification (PMID: 25169980). 25169980
FGFR2 K310R FGFR2 N549K endometrial cancer sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of endometrial cancer cells harboring FGFR2 K310R and FGFR2 N549K mutations in culture (PMID: 25169980). 25169980
FGFR2 - PHGDH intrahepatic cholangiocarcinoma predicted - sensitive Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 treatment led to inhibition of growth in an intrahepatic cholangiocarcinoma cell line expressing FGFR2-PHGDH in culture, demonstrating decreased phosphorylation of Frs2 and Erk1/2 (PMID: 33926920). 33926920
FGFR2 fusion FGFR2 N550H intrahepatic cholangiocarcinoma decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 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 act mut Advanced Solid Tumor sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 (CH5183284) dosing regimen has been determined in solid tumor patients with activating FGFR3 alterations (JCO, Vol 33, No 15_suppl (May 20 Supplement), 2015: 2540). detail...
FGFR3 - TACC3 transitional cell carcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in two patients with urothelial cancer harboring FGFR3-TACC3 (PMID: 30745300; NCT01948297). 30745300
FGFR1 fusion Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR3 N540K Advanced Solid Tumor decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 N540K demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). 28034880
FGFR2 amp breast cancer sensitive Debio 1347 Preclinical Actionable In a preclinical study, Debio 1347 inhibited proliferation of breast cancer cell lines harboring FGFR2 amplification in culture (PMID: 25169980). 25169980
FGFR2 amp breast cancer sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a stable disease with 19.4% reduction of tumor size and 41% decrease of DUSP6 score in a patient with lung squamous cell carcinoma harboring FGFR2 amplification (PMID: 30745300; NCT01948297). 30745300
FGFR3 - BAIAP2L1 urinary bladder cancer sensitive Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 inhibited proliferation of a bladder cancer cell line harboring an FGFR3-BAIAP2L1 fusion in culture (PMID: 25169980). 25169980
FGFR3 - BAIAP2L1 urinary bladder cancer sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 decreased phosphorylation of ERK and FRS and inhibited proliferation of a bladder cancer cell line harboring FGFR3-BAIAP2L1 in culture, and inhibited tumor growth in bladder cancer cell line xenograft models with FGFR3-BAIAP2L1 (PMID: 25589496) 25589496
FGFR3 - TACC3 gallbladder cancer predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in stable disease in a patient with gallbladder cancer harboring FGFR3-TACC3 (PMID: 30745300; NCT01948297). 30745300
FGFR3 - TACC3 urinary bladder cancer sensitive Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 inhibited proliferation of bladder cancer cell lines harboring an FGFR3-TACC3 fusion in culture and inhibited tumor growth in FGFR3-TACC3-positive bladder cancer cell line xenograft models (PMID: 25169980). 25169980
FGFR3 L608V Advanced Solid Tumor decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 L608V demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). 28034880
FGFR3 V555M Advanced Solid Tumor decreased response Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FGFR3 V555M demonstrated reduced sensitivity to Debio 1347 in culture (PMID: 28034880). 28034880
FGFR2 fusion Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 V564L Advanced Solid Tumor resistant Debio 1347 Preclinical - Cell culture Actionable In a preclinical study, Debio 1347 did not inhibit Fgfr2 phosphorylation in transformed cells over expressing FGFR2 V564L in culture (PMID: 25169980). 25169980
FGFR2 - KIAA1217 cholangiocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in stable disease in a patient with cholangiocarcinoma harboring FGFR2-KIAA1217 (PMID: 30745300; NCT01948297). 30745300
FGFR3 mutant Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR3 fusion Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 amp Advanced Solid Tumor predicted - sensitive Debio 1347 Phase I Actionable In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). 30745300
FGFR2 amp FGFR2 mut cervical adenocarcinoma predicted - sensitive Debio 1347 Case Reports/Case Series Actionable In a Phase I trial, Debio 1347 treatment resulted in a partial response with 50% reduction of tumor size and 56% decrease of DUSP6 score in a patient with cervical adenocarcinoma harboring FGFR2 amplification and FGFR2 mutation (PMID: 30745300; NCT01948297). 30745300

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01948297 Phase I Debio 1347 Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations Terminated USA 4
NCT03834220 Phase II Debio 1347 Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) Active, not recruiting USA 22


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