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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.

NCT04275518 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-10-15

No results posted yet for this study

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).

Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndromes (MDS)

Interventions

DRUG

APG-115

APG-115 orally once daily from Days 1 to 7 every 28 days.

DRUG

Azacitidine

75 mg/m\^2 SC QD on Days 1- 7 (28-day cycle)

DRUG

Cytarabine

1g/m\^2 IV QD on Days 3-7 (28-day cycle)

Sponsors & Collaborators

  • Suzhou Yasheng Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Jianxiang Wang, M.D. · Blood Diseases Hospital Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275518 on ClinicalTrials.gov