^
    1d
    PK and PK/PD Modeling of Bcl2 Inhibitor S65487 in Patients With AML and Investigation of Nonlinearity With Microdosing. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    This optimized model demonstrated significant improvement, reducing the difference in the description of exposure for the microdose study from 5- to 1-fold, without compromising the description at therapeutic doses. This modified model has a wider range of applicability across doses and could support the extrapolation of microdose study results to therapeutic doses in future research.
    PK/PD data • Journal
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL2L11 (BCL2 Like 11)
    |
    S65487
    2ms
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Institut de Recherches Internationales Servier | Completed --> Active, not recruiting
    Enrollment closed
    |
    azacitidine • S65487
    3ms
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed
    Trial completion
    |
    azacitidine • S65487
    1year
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    azacitidine • S65487
    over1year
    Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=60, Terminated, Institut de Recherches Internationales Servier | Completed --> Terminated; The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.
    Trial termination
    |
    S65487
    almost2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy
    |
    MIK665 • S65487
    2years
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=57, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting | N=109 --> 57
    Enrollment closed • Enrollment change
    |
    azacitidine • S65487
    2years
    CL1-65487-003: Phase I/II Trial of S65487 Plus Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=109, Recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jan 2026 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    azacitidine • S65487
    2years
    Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P1, N=60, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> Nov 2023 | Trial primary completion date: Jul 2023 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    S65487
    over2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Combination therapy
    |
    MIK665 • S65487
    over2years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2023 --> Apr 2024
    Trial completion date • Combination therapy
    |
    MIK665 • S65487
    almost3years
    VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma) (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2024 --> Dec 2023 | Trial primary completion date: Sep 2024 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    MIK665 • S65487