drugset
drugset / Trial / NCT04358393

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

NCT04358393 ↗

Phase 1/2 Unknown 69 enrolled Ascentage Pharma Group Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-12-04
Primary completion
2024-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Alrizomadlin Small molecule 100 mg Oral
Subject Alrizomadlin Small molecule 150 mg Oral
Subject Alrizomadlin Small molecule 200 mg Oral
Subject Alrizomadlin Small molecule 250 mg Oral
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous

Indications

acute myeloid leukemia chronic myelomonocytic leukemia myelodysplastic syndrome