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Therapy Name FF-10101
Synonyms
Therapy Description

FF-10101 is a second generation and irreversible inhibitor of Flt3, including the internal tandem duplication (FLT3-ITD) and known resistance mutations (D835Y, Y842C, Y842H, or F691L) and also inhibits Kit and Csf1r (Fms) (PMID: 29187377)

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Drug Name Trade Name Synonyms Drug Classes Drug Description
FF-10101 FF-10101-01|FF10101|FF 10101 CSF1R Inhibitor 26 FLT3 Inhibitor 60 KIT Inhibitor 53 FF-10101 is a second generation and irreversible inhibitor of Flt3, including the internal tandem duplication (FLT3-ITD) and known resistance mutations (D835Y, Y842C, Y842H, or F691L) and also inhibits Kit and Csf1r (Fms) (PMID: 29187377, PMID: 32722298)

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins FLT3 D835Y acute myeloid leukemia sensitive FF-10101 Preclinical - Cell line xenograft Actionable In a preclinical study, FF-10101 inhibited Flt3 autophosphorylation and growth of leukemic cell lines and inhibited growth of cell line xenografts with FLT3-ITD/D835Y compound mutations (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 D835Y acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 D835Y in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 M664I hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 M664I in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 C790S hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 C790S in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins acute myeloid leukemia sensitive FF-10101 Phase I Actionable In a Phase I trial, FF-10101 treatment was well tolerated, and resulted in a composite complete remission (CRc) in 13% (4/30) and a partial remission (PR) in 13% (4/30) of patients with relapsed or refractory acute myeloid leukemia, 1 of the patients achieved CRc and 2 of the patients achieved PR harbored FLT3 ITD mutations (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 7008-7008; NCT03194685). detail...
FLT3 exon 14 ins acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins acute myeloid leukemia sensitive FF-10101 Preclinical - Pdx & cell culture Actionable In a preclinical study, FF-10101 inhibited Flt3 autophosphorylation and cell growth of leukemic cells in culture and in AML-patient-derived xenograft models with FLT3-ITD mutations (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 A848P acute myeloid leukemia predicted - sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, acute myeloid leukemia cells harboring FLT3-ITD and FLT3 A848P demonstrated sensitivity to treatment with FF-10101 in culture (PMID: 35395091). 35395091
KIT D816V hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101, as compared to Quizartinib, inhibited cell proliferation of transformed 32Dcl3 murine myeloid cells expressing human Kit D816V (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 D835H acute myeloid leukemia sensitive FF-10101 Preclinical - Pdx Actionable In a preclinical study, FF-10101 inhibited cell growth in AML-patient-derived xenograft models with FLT3-ITD/D835H compound mutations (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 D835H acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 D835H in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D698N hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D698N in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 F691L hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells harboring FLT3-ITD and FLT3 F691L demonstrated sensitivity to treatment with FF-10101 in culture, but were less sensitive compared to cells expressing FLT3-ITD alone (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y842C acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 Y842C in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835F hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835F in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 N841K acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 N841K in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D698N FLT3 D835V hematologic cancer predicted - resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD with FLT3 D698N and D835V were moderately resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 K429E hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 K429E in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835A hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835A in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 F691L acute myeloid leukemia sensitive FF-10101 Preclinical - Cell line xenograft Actionable In a preclinical study, FF-10101 inhibited Flt3 autophosphorylation and growth of leukemic cell lines and inhibited growth of cell line xenografts with FLT3-ITD/F691L compound mutations (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 F691L acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, acute myeloid leukemia cells harboring FLT3-ITD and FLT3 F691L demonstrated sensitivity to treatment with FF-10101 in culture, but were less sensitive compared to cells harboring FLT3-ITD alone (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835G hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835G in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 C807S hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 C807S in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y693C FLT3 D835V hematologic cancer resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD with FLT3 Y693C and D835V were resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835V hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835V in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y693F hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 Y693F in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835I hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835I in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins NRAS Q61K acute myeloid leukemia resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, acute myeloid leukemia cells harboring a FLT3-ITD mutation and expressing NRAS Q61K demonstrated resistance to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 C828S hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 C828S in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 N841Y acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 N841Y in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y693C hematologic cancer resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD and FLT3 Y693C were resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835N acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 D835N in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835Y hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835Y in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y693N hematologic cancer predicted - resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD and FLT3 Y693N were moderately resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 F691L FLT3 D835V hematologic cancer predicted - resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD with FLT3 F691L and D835V were moderately resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835del hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835del in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 C695S hematologic cancer predicted - resistant FF-10101 Preclinical - Biochemical Actionable In a preclinical study, FF-10101 treatment failed to inhibit Flt3 phosphorylation in transformed human cells expressing FLT3-ITD and FLT3 C695S in culture (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 C695S hematologic cancer predicted - resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD and FLT3 C695S were resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835V acute myeloid leukemia sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of acute myeloid leukemia cells harboring FLT3-ITD and FLT3 D835V in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 C681S hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 C681S in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835E hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835E in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 N676K hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 N676K in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835H hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835H in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 D835N hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 D835N in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 Y842C hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101, as compared to Quizartinib, inhibited Flt3 autophosphorylation and cell proliferation of transformed 32Dcl3 murine myeloid cells expressing a human FLT3-ITD/Y842C compound mutation (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 Y842H hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101, as compared to Quizartinib, inhibited Flt3 autophosphorylation and cell proliferation of transformed 32Dcl3 murine myeloid cells expressing a human FLT3-ITD/Y842H compound mutation (PMID: 29187377). 29187377
FLT3 exon 14 ins FLT3 C694S hematologic cancer sensitive FF-10101 Preclinical - Cell culture Actionable In a preclinical study, FF-10101 treatment inhibited growth of transformed hematologic cells expressing FLT3-ITD and FLT3 C694S in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins NRAS G12C acute myeloid leukemia resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, acute myeloid leukemia cells harboring a FLT3-ITD mutation and expressing NRAS G12C demonstrated resistance to treatment with FF-10101 in culture (PMID: 35395091). 35395091
FLT3 exon 14 ins FLT3 G697S hematologic cancer predicted - resistant FF-10101 Preclinical - Cell culture Actionable In a preclinical study, transformed hematologic cells expressing FLT3-ITD and FLT3 G697S were moderately resistant to treatment with FF-10101 in culture (PMID: 35395091). 35395091

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03194685 Phase Ib/II FF-10101 Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Completed USA 0


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