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A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 15, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary completion date: Jun 30, 2023 to Dec 31, 2025 Completion date: Dec 30, 2023 to Dec 31, 2025v9 Show 1 more changeShow less
    • Completion date: Dec 30, 2023 to Dec 31, 2025
  3. Primary completion date: Mar 20, 2022 to Jun 30, 2023 Enrollment target: 90 to 102 · Study sites: 11 to 14 · Completion date: Aug 20, 2022 to Dec 30, 2023 · 1 morev8 Show 4 more changesShow less
    • Enrollment target: 90 to 102
    • Study sites: 11 to 14
    • Completion date: Aug 20, 2022 to Dec 30, 2023
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 1 to 11v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Collaborators expanded, about 5 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Start date changed from estimate of Jul 2020 to Jul 6, 2020v4
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2020 to Jul 2020 · Study sites: 0 to 1v3 Show 2 more changesShow less
    • Start date: Feb 2020 to Jul 2020
    • Study sites: 0 to 1
  4. Start date: Feb 10, 2020 to Feb 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation. APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models. This is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R/R AML or MDS subjects. Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).
Trial Details
NCT Number NCT04275518
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS)
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov