OncoMatch/Clinical Trials/NCT04275518
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Is NCT04275518 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including APG-115 and Azacitidine for acute myeloid leukemia (aml).
Treatment: APG-115 · Azacitidine · Cytarabine — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: leukemia biotherapy
Patients must not have had leukemia biotherapy 4 weeks prior to starting investigational drug
Cannot have received: small molecular targeted drug therapy
less than 5 half-lives small molecular targeted drug therapy
Cannot have received: any anti-cancer therapy
28 days any anti-cancer therapy (whichever is longer)
Cannot have received: allogeneic hematopoietic stem cell transplant
Participants who have received allogeneic HSCT
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 12 months
autologous HSCT within 12 months
Cannot have received: MDM2-p53 inhibitor
Any prior systemic MDM2-p53 inhibitor treatment
Lab requirements
Blood counts
white blood cell count < 50 × 10^9/L (hydroxyurea permitted to meet this criterion)
Kidney function
Liver function
Adequate organ function; Subject has a white blood cell count< 50 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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