Molecular Profile Detail

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Profile Name IDH1 R132X
Gene Variant Detail

IDH1 R132X (unknown)

Relevant Treatment Approaches IDH Inhibitor (Pan) IDH1 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 R132X acute myeloid leukemia predicted - sensitive CG-806 Preclinical - Patient cell culture Actionable In a preclinical study, patient-derived acute myeloid leukemia cells harboring IDH1 R132X mutations demonstrated increased sensitivity to CG-806 compared to wild-type cells in culture (Proceedings of the American Association for Cancer Research, Vol 60, Mar 2019, Abstract #1323). detail...
IDH1 R132X acute myeloid leukemia sensitive IDH1 Inhibitor IDH305 Phase I Actionable In a Phase I trial, IDH305 treatment resulted in objective response in 33% (7/21) of acute myeloid leukemia patients harboring IDH1 R132 mutations, including complete remission in 3 (14%) and partial remission in 4 (19%) patients (Blood 2016 128 (22):1073). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02746081 Phase I BAY1436032 Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors Active, not recruiting
NCT04493164 Phase II CPX-351 + Ivosidenib Ivosidenib CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Not yet recruiting
NCT02381886 Phase I IDH305 A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations Active, not recruiting
NCT04250051 Phase I Cytarabine + Filgrastim + Fludarabine + Ivosidenib Ivosidenib Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia Not yet recruiting
NCT02677922 Phase Ib/II Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Active, not recruiting
NCT02719574 Phase I Cytarabine + Olutasidenib Olutasidenib Azacitidine + Olutasidenib Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation Recruiting
NCT03684811 Phase Ib/II Cisplatin + Gemcitabine + Olutasidenib Azacitidine + Olutasidenib Olutasidenib Nivolumab + Olutasidenib A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation Active, not recruiting
NCT03564821 Phase I Ivosidenib IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation Recruiting
NCT03914742 Phase Ib/II Pamiparib + Temozolomide BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations Recruiting
NCT03528642 Phase I Radiotherapy + Telaglenastat + Temozolomide CB-839 With Radiation Therapy and Temozolomide in Treating Participants With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma Recruiting
NCT02977689 Phase II IDH305 Trial of IDH305 in IDH1 Mutant Grade II or III Glioma Withdrawn
NCT04013880 Phase Ib/II ASTX727 + Olutasidenib ASTX727 and FT-2102 in Treating IDH1-Mutated Recurrent/Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia Withdrawn
NCT03471260 Phase Ib/II Ivosidenib + Venetoclax Study of Venetoclax With the mIDH1 Inhibitor Ivosidenib (AG120) in IDH1-Mutated Hematologic Malignancies Recruiting
NCT02074839 Phase I Ivosidenib Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation Recruiting