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A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS

NCT04358393 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-02-01

No results posted yet for this study

Summary

This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and tolerability of APG-115 as a single agent in Part 1, followed by a combination of APG-115 + 5-azacitidine (5-AZA) in Part 2.

Conditions

Interventions

DRUG

APG-115

APG-115 given once daily on day 1-5 of every 28 day cycle

DRUG

5-azacitidine

5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Yifan Zhai, MD, PhD · Ascentage Pharma Group Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2024-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04358393 on ClinicalTrials.gov