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

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 xen

Trial Details

NCT ID
NCT04275518
Phase
PHASE1
Sponsor
Ascentage Pharma Group Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • APG-115
  • Azacitidine
  • Cytarabine
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia by WHO classification or relapsed/progres…
  • Age \>/= 18 years.
  • Adequate organ function
  • Subject must have a projected life expectancy of at least 12 weeks.

For full eligibility, visit ClinicalTrials.gov.

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