A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Status:
Recruiting
Trial end date:
2022-08-20
Target enrollment:
Participant gender:
Summary
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).