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    DRUG:

    HMPL-306

    i
    Other names: HMPL-306, HMPL306, HMPL 306
    Associations

    News

    Trials
    Company:
    Hutchmed
    Drug class:
    IDH1 inhibitor, IDH2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    11d
    Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects (clinicaltrials.gov)
    P1, N=8, Not yet recruiting, Hutchmed
    New P1 trial
    |
    HMPL-306
    23d
    A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations (clinicaltrials.gov)
    P1, N=90, Active, not recruiting, Hutchmed | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HMPL-306
    6ms
    A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P3, N=316, Recruiting, Hutchmed | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cytarabine • azacitidine • HMPL-306
    7ms
    A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P3, N=316, Not yet recruiting, Hutchmed
    New P3 trial
    |
    cytarabine • azacitidine • HMPL-306
    9ms
    A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH (clinicaltrials.gov)
    P1, N=75, Recruiting, Hutchmed | Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 R132H • IDH2 R172K • IDH1 R132C • IDH1 R132 • IDH2 R140Q • IDH2 R172
    |
    HMPL-306
    9ms
    A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations (clinicaltrials.gov)
    P1, N=90, Active, not recruiting, Hutchmed | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HMPL-306
    over1year
    A PHASE 1 STUDY OF HMPL-306, A DUAL INHIBITOR OF MUTANT ISOCITRATE DEHYDROGENASE (IDH) 1 AND 2, IN PTS WITH RELAPSED/REFRACTORY MYELOID HEMATOLOGICAL MALIGNANCIES HARBORING IDH1 AND/OR 2 MUTATIONS (EHA 2023)
    Combing with safety, tolerability, PK/PD and preliminary efficacy, the RP2D was set as 250 mg QD at Cycle 1, and then with 150 mg QD from Cycle 2. Dose expansion is ongoing. Clinical trialinformation: NCT04272957.
    Clinical • P1 data
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation • IDH2 R172K • IDH1 R132C • IDH1 R132 • IDH2 R140Q • IDH2 R172
    |
    HMPL-306
    over1year
    A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH (clinicaltrials.gov)
    P1, N=75, Recruiting, Hutchmed | Trial completion date: Jan 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 R132H • IDH2 R172K • IDH1 R132C • IDH1 R132 • IDH2 R140Q • IDH2 R172
    |
    HMPL-306
    over1year
    A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations (clinicaltrials.gov)
    P1, N=90, Recruiting, Hutchmed | Trial completion date: Jan 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    HMPL-306
    over1year
    Preclinical characteristic of HMPL-306, a CNS-penetrable dual inhibitor of mutant IDH1 and IDH2 (AACR 2023)
    Oral administration of HMPL-306 remarkably decreased 2-HG level in plasma and tumor tissues in xenograft models carrying mIDH1 or mIDH2 and the inhibition is more potent and durable than either ivosidenib or enasidenib at the same dose...Combination treatment of HMPL-306 and azacitidine synergized in releasing the differentiation block in mIDH AML cells. HMPL-306 is a potent, dual inhibitor of IDH1/2 mutation. The strong activity and favorable PK profiles support further clinical evaluation.
    Preclinical
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation • IDH1 R132H • IDH2 R172K • IDH wild-type • IDH1 R132 • IDH2 R140Q • IDH2 R172
    |
    azacitidine • Tibsovo (ivosidenib) • Idhifa (enasidenib) • HMPL-306
    almost3years
    A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations (ASH 2021)
    Safety endpoints will include dose limiting toxicities, treatment emergent adverse event and serious adverse events. Efficacy endpoints will include objective response rate, time to response, and duration of response.
    Clinical • P1 data
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH1 mutation • IDH2 mutation
    |
    HMPL-306
    over4years
    A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms (clinicaltrials.gov)
    P1, N=75, Recruiting, Hutchison Medipharma Limited | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    HMPL-306
    over4years
    A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms (clinicaltrials.gov)
    P1, N=75, Not yet recruiting, Hutchison Medipharma Limited
    Clinical • New P1 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    HMPL-306