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

AML, Adult Clinical Trial

Official title:
A Phase Ib/II Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AML), Mixed Phenotype Acute Leukemia (MPAL), Chronic Myelomonocytic Leukemia (CMML) and Higher-Risk Myelodysplastic Syndrome (MDS

Clinical Trial 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)

Clinical Trial Description

The patients with histologically confirmed relapsed or refractory (R/R) AML/MPAL/CMML or relapsed/refractory Higher-Risk MDS by WHO classification for which no available standard therapies are indicated or anticipated to result in a durable response will be enrolled. This will be a 3+3 dose escalation to determine the DLTs and MTD/RP2D of APG-2575 (see dose escalation table) given in combination with Azacitidine ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04964518
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact Angela Kaiser
Phone 301-509-0357
Email angela.kaiser@ascentage.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 30, 2021
Completion date October 30, 2024
View Details
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