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    BIOMARKER:

    IDH1 mutation

    i
    Entrez ID:
    3417
    Related biomarkers:
    Expression
    Mutation
    Others
    Related tests:
    Apply
    IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up (NCT04242849)
    Phase N/A
    Josep Carreras Leukaemia Research Institute
    Completed
    Last update posted :
    02/21/2025
    Initiation :
    05/23/2016
    Primary completion :
    12/27/2019
    Completion :
    01/16/2020
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation
    Study of Olutasidenib and Temozolomide in HGG (NCT06161974)
    Phase 2
    Rigel Pharmaceuticals
    Recruiting
    Last update posted :
    02/21/2025
    Initiation :
    03/01/2025
    Primary completion :
    06/01/2029
    Completion :
    06/01/2035
    IDH1
    |
    IDH1 mutation
    |
    temozolomide • Rezlidhia (olutasidenib)
    A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG) (NCT05099003)
    Phase 1/2
    National Cancer Institute (NCI)
    Suspended
    Last update posted :
    02/18/2025
    Initiation :
    05/31/2022
    Primary completion :
    06/30/2027
    Completion :
    06/30/2027
    BRAF • IDH1
    |
    BRAF mutation • BRAF V600 • IDH1 mutation
    |
    Xpovio (selinexor)
    All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma (NCT05345002)
    Phase 2
    Stephen Bagley, MD, MSCE
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    11/16/2022
    Primary completion :
    06/01/2026
    Completion :
    06/01/2027
    IDH1 • IDH2 • MGMT
    |
    IDH1 mutation • IDH2 mutation
    |
    Zynyz (retifanlimab-dlwr)
    A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma (NCT04576117)
    Phase 3
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/07/2025
    Initiation :
    02/16/2021
    Primary completion :
    12/30/2026
    Completion :
    12/30/2026
    BRAF • IDH1 • NF1
    |
    BRAF V600E • BRAF V600 • IDH1 mutation • IDH mutation + BRAF V600E
    |
    Koselugo (selumetinib) • vinblastine
    Seizure Treatment in Glioma (STING) (NCT03048084)
    Phase 4
    Leiden University Medical Center
    Recruiting
    Last update posted :
    02/04/2025
    Initiation :
    02/01/2018
    Primary completion :
    07/01/2026
    Completion :
    07/01/2028
    IDH1
    |
    IDH1 mutation • IDH wild-type
    Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors (NCT02746081)
    Phase 1
    Bayer
    Completed
    Last update posted :
    12/18/2024
    Initiation :
    05/26/2016
    Primary completion :
    11/08/2018
    Completion :
    12/03/2024
    IDH1
    |
    IDH1 mutation • IDH1 R132
    |
    BAY1436032
    A Study of Gilteritinib in Combination with Ivosidenib or Enasidenib in People with Acute Myeloid Leukemia (AML) (NCT05756777)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    11/12/2024
    Initiation :
    06/26/2023
    Primary completion :
    02/01/2025
    Completion :
    02/01/2025
    FLT3 • IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation • FLT3 mutation
    |
    Xospata (gilteritinib) • Tibsovo (ivosidenib) • Idhifa (enasidenib)
    Telaglenastat With Radiation Therapy and Temozolomide in Treating Patients With IDH-Mutated Diffuse Astrocytoma or Anaplastic Astrocytoma (NCI-2018-00876) (NCT03528642)
    Phase 1
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    05/01/2019
    Primary completion :
    12/05/2024
    Completion :
    12/05/2024
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation
    |
    temozolomide • telaglenastat (CB-839)
    A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer (NCT03423628)
    Phase 1
    AstraZeneca
    Recruiting
    Last update posted :
    05/20/2024
    Initiation :
    04/02/2018
    Primary completion :
    04/22/2026
    Completion :
    04/22/2026
    IDH1
    |
    IDH1 mutation
    |
    AZD1390
    XmAb20717 in Advanced Biliary Tract Cancers (NCT05297903)
    Phase 2
    Abramson Cancer Center at Penn Medicine
    Active, not recruiting
    Last update posted :
    05/07/2024
    Initiation :
    04/11/2022
    Primary completion :
    12/31/2024
    Completion :
    12/31/2024
    FGFR2 • IDH1 • NTRK
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion • NTRK fusion
    |
    vudalimab (XmAb717)
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (NCT04641871)
    Phase 1
    Symphogen A/S
    Active, not recruiting
    Last update posted :
    04/24/2024
    Initiation :
    10/12/2020
    Primary completion :
    06/01/2024
    Completion :
    06/01/2024
    FGFR2 • IDH1
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome (IDIOME-STUDY) (NCT03503409)
    Phase 2
    Groupe Francophone des Myelodysplasies
    Active, not recruiting
    Last update posted :
    04/19/2024
    Initiation :
    05/14/2019
    Primary completion :
    04/02/2025
    Completion :
    04/02/2025
    IDH1
    |
    IDH1 mutation
    |
    Tibsovo (ivosidenib)
    Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors (INNATE) (NCT04669899)
    Phase 1/2
    Jounce Therapeutics, Inc.
    Completed
    Last update posted :
    04/09/2024
    Initiation :
    01/12/2021
    Primary completion :
    11/28/2023
    Completion :
    11/28/2023
    EGFR • PD-L1 • ALK • IDH1 • FGFR
    |
    EGFR mutation • IDH1 mutation • ALK rearrangement • FGFR mutation
    |
    pimivalimab (JTX-4014) • polzastobart (JTX-8064)
    Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE) (NCT03173248)
    Phase 3
    Institut de Recherches Internationales Servier
    Active, not recruiting
    Last update posted :
    04/05/2024
    Initiation :
    06/26/2017
    Primary completion :
    03/18/2021
    Completion :
    06/30/2026
    IDH1
    |
    IDH1 mutation
    |
    azacitidine • Tibsovo (ivosidenib)
    Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas (REVOLUMAB) (NCT03925246)
    Phase 2
    Assistance Publique - Hôpitaux de Paris
    Completed
    Last update posted :
    04/02/2024
    Initiation :
    07/30/2019
    Primary completion :
    12/02/2020
    Completion :
    08/18/2021
    PD-L1 • TMB • IDH1 • IDH2 • MGMT • CD8 • PD-1 • ATRX • CD163 • CD4 • CD68 • FOXP3 • GFAP • OLIG2
    |
    IDH1 mutation • IDH2 mutation • IDH1 R132
    |
    Opdivo (nivolumab) • temozolomide
    Proton Radiation Therapy for Gliomas (NCT01358058)
    Phase N/A
    Massachusetts General Hospital
    Active, not recruiting
    Last update posted :
    03/27/2024
    Initiation :
    05/01/2011
    Primary completion :
    05/01/2025
    Completion :
    11/01/2025
    IDH1
    |
    IDH1 mutation
    Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation (NCT02481154)
    Phase 1
    Institut de Recherches Internationales Servier
    Active, not recruiting
    Last update posted :
    03/22/2024
    Initiation :
    06/01/2015
    Primary completion :
    10/17/2022
    Completion :
    03/01/2024
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation
    |
    Voranigo (vorasidenib)
    ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas (NCT05609994)
    Phase 1
    Katy Peters, MD, PhD
    Not yet recruiting
    Last update posted :
    03/21/2024
    Initiation :
    06/01/2024
    Primary completion :
    08/01/2025
    Completion :
    08/01/2027
    IDH1
    |
    IDH1 mutation • IDH1 R132
    |
    Voranigo (vorasidenib)
    A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery (POLO) (NCT04702581)
    Phase 3
    Hospices Civils de Lyon
    Recruiting
    Last update posted :
    03/18/2024
    Initiation :
    12/07/2021
    Primary completion :
    12/01/2030
    Completion :
    12/01/2030
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation
    IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation (NCT03564821)
    Phase 1
    Massachusetts General Hospital
    Completed
    Last update posted :
    03/08/2024
    Initiation :
    01/16/2019
    Primary completion :
    05/22/2022
    Completion :
    06/06/2023
    IDH1 • HLA-B
    |
    IDH1 mutation • IDH1 R132
    |
    Tibsovo (ivosidenib)
    An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma (NCT05223816)
    Phase 2
    Virogin Biotech Canada Ltd
    Recruiting
    Last update posted :
    03/07/2024
    Initiation :
    01/24/2024
    Primary completion :
    10/01/2025
    Completion :
    12/31/2025
    MSI • IDH1
    |
    MSI-H/dMMR • IDH1 mutation
    |
    Opdivo (nivolumab) • VG161
    SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (NCT05163080)
    Phase 2
    MimiVax, LLC
    Active, not recruiting
    Last update posted :
    02/26/2024
    Initiation :
    11/18/2021
    Primary completion :
    08/18/2024
    Completion :
    08/18/2024
    IDH1 • MGMT • CD8
    |
    IDH1 mutation
    |
    temozolomide • SurVaxM (SVN53-67/M57-KLH peptide vaccine)
    Pediatric Low Grade Glioma - MEKinhibitor TRIal vs Chemotherapy (PLGG - MEKTRIC) (NCT05180825)
    Phase 2
    University Hospital, Strasbourg, France
    Recruiting
    Last update posted :
    02/19/2024
    Initiation :
    05/05/2022
    Primary completion :
    11/01/2031
    Completion :
    12/01/2031
    BRAF • IDH1 • NF1 • MYBL1
    |
    IDH1 mutation
    |
    Mekinist (trametinib) • vinblastine
    Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (NCT02704858)
    Phase 1/2
    Neonc Technologies, Inc.
    Recruiting
    Last update posted :
    02/15/2024
    Initiation :
    04/08/2016
    Primary completion :
    06/01/2024
    Completion :
    12/01/2024
    IDH1
    |
    IDH1 mutation
    |
    perillyl alcohol (NEO100)
    A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia (NCT06017258)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    01/24/2024
    Initiation :
    08/22/2023
    Primary completion :
    08/22/2026
    Completion :
    08/22/2026
    FLT3 • IDH1 • IDH2 • IL18 • CD37
    |
    FLT3-ITD mutation • IDH1 mutation • IDH2 mutation • CD37 expression
    |
    CD371-YSNVZ-IL18 CAR T cells
    IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor (NCT05814536)
    Phase 1
    AnHeart Therapeutics Inc.
    Recruiting
    Last update posted :
    12/14/2023
    Initiation :
    05/06/2023
    Primary completion :
    08/01/2025
    Completion :
    05/01/2026
    IDH1
    |
    IDH1 mutation
    |
    safusidenib (DS-1001)
    A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma (NCT04458272)
    Phase 2
    Daiichi Sankyo Co., Ltd.
    Active, not recruiting
    Last update posted :
    12/11/2023
    Initiation :
    07/08/2020
    Primary completion :
    03/10/2023
    Completion :
    06/30/2026
    IDH1
    |
    IDH1 mutation • IDH1 R132
    |
    safusidenib (DS-1001)
    A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2 (NCT03152318)
    Phase 1
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    08/08/2023
    Initiation :
    07/18/2017
    Primary completion :
    12/01/2024
    Completion :
    12/01/2025
    IDH1
    |
    IDH1 mutation • IDH1 R132H • IDH wild-type • IDH1 R132
    |
    cyclophosphamide • CAN-3110
    Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients (GLORIA) (NCT04121455)
    Phase 1/2
    TME Pharma AG
    Active, not recruiting
    Last update posted :
    06/22/2023
    Initiation :
    09/12/2019
    Primary completion :
    12/01/2024
    Completion :
    12/01/2024
    IDH1
    |
    IDH1 mutation
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • olaptesed pegol (NOX-A12)
    A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms (NCT04955938)
    Phase 1
    University of Chicago
    Recruiting
    Last update posted :
    04/28/2023
    Initiation :
    10/29/2021
    Primary completion :
    10/01/2025
    Completion :
    10/01/2025
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation
    |
    Tibsovo (ivosidenib) • Idhifa (enasidenib) • Inrebic (fedratinib)
    6 Months Adjuvant Temozolomide (TMZ) vs No Adjuvant TMZ in Newly Diagnosed MGMT Methylated Glioblastoma (GBM) (NCT04926168)
    Phase N/A
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Withdrawn
    Last update posted :
    08/10/2022
    Initiation :
    03/01/2023
    Primary completion :
    12/31/2025
    Completion :
    12/31/2026
    IDH1 • IDH2 • MGMT
    |
    IDH1 mutation • IDH wild-type
    |
    temozolomide
    Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation (NCT04655391)
    Phase 1b
    City of Hope Medical Center
    Withdrawn
    Last update posted :
    06/09/2022
    Initiation :
    06/25/2022
    Primary completion :
    12/15/2023
    Completion :
    12/15/2023
    FLT3 • ABL1 • BCR • IDH1 • AXL
    |
    IDH1 mutation • BCR-ABL1 fusion • FLT3 mutation • FLT3 D835 • IDH1 R132 • FLT3 I836
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine • Bosulif (bosutinib) • decitabine • Tibsovo (ivosidenib) • Idhifa (enasidenib) • Daurismo (glasdegib)
    Olaparib in Recurrent IDH-mutant Glioma (OLAGLI) (NCT03561870)
    Phase 2
    Hospices Civils de Lyon
    Completed
    Last update posted :
    04/29/2022
    Initiation :
    03/20/2019
    Primary completion :
    11/08/2021
    Completion :
    11/24/2021
    IDH1 • IDH2
    |
    IDH1 mutation • IDH2 mutation • IDH1 R132H • IDH1 R132
    |
    Lynparza (olaparib)
    ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors (NCT04737174)
    Phase 2
    ES Therapeutics Australia Pty Ltd
    Withdrawn
    Last update posted :
    04/06/2022
    Initiation :
    03/25/2021
    Primary completion :
    10/01/2021
    Completion :
    04/01/2022
    IDH1
    |
    IDH1 mutation
    A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS (NCT04044209)
    Phase 2
    Yale University
    Withdrawn
    Last update posted :
    01/20/2022
    Initiation :
    02/12/2020
    Primary completion :
    09/01/2021
    Completion :
    09/01/2023
    PD-L1 • IDH1
    |
    IDH1 mutation
    |
    Opdivo (nivolumab) • Tibsovo (ivosidenib)
    A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy (HOVON150AML) (NCT03839771)
    Phase 3
    Stichting Hemato-Oncologie voor Volwassenen Ned...
    Recruiting
    Last update posted :
    09/01/2021
    Initiation :
    03/01/2019
    Primary completion :
    03/01/2023
    Completion :
    03/01/2033
    FLT3 • IDH1 • IDH2 • UGT1A1
    |
    IDH1 mutation • IDH2 mutation • FLT3 mutation • IDH1 R132 • UGT1A1*1*1 • FLT3 mutation + IDH1 mutation • IDH2 R140 • IDH2 R172 • UGT1A1 mutation
    |
    Tibsovo (ivosidenib) • Idhifa (enasidenib)
    Safety,Tolerability, Pharmacokinetic,Pharmacodynamics and Efficacy of KY100001 in Patients With Advanced Solid Tumors (NCT04906473)
    Phase 1
    Kunming Pharmaceuticals, Inc.
    Not yet recruiting
    Last update posted :
    05/28/2021
    Initiation :
    07/31/2021
    Primary completion :
    12/31/2022
    Completion :
    10/31/2023
    IDH1
    |
    IDH1 mutation
    |
    KY100001
    Revision of the EORTC QLQ-BN20 Questionnaire (QLQBN20) (NCT04689321)
    Phase N/A
    Leiden University Medical Center
    Recruiting
    Last update posted :
    12/30/2020
    Initiation :
    12/19/2018
    Primary completion :
    01/01/2024
    Completion :
    01/01/2024
    IDH1
    |
    IDH1 mutation • IDH wild-type
    11C-Methionine PET as Prognostic Marker of Gliomas (NCT02518061)
    Phase N/A
    Istituto Clinico Humanitas
    Completed
    Last update posted :
    10/01/2020
    Initiation :
    07/01/2015
    Primary completion :
    12/31/2018
    Completion :
    12/31/2018
    IDH1 • MGMT
    |
    IDH1 mutation • MGMT promoter methylation