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A Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML)

NCT04964518 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-25

No results posted yet for this study

Summary

This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy and PK of APG-2575 in combination with Azacitidine in the patients with AML/MPAL or MDS/CMML. The study consists of dose escalation (Part I) and dose expansion phase (Part II)

Conditions

  • AML, Adult

Interventions

DRUG

APG 2575 ramp up arm

APG2575 ramp up + Azacitidine

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Qian Niu, MD · Ascentage Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2024-07-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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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 NCT04964518 on ClinicalTrials.gov