Trial intelligence / Profile preview

APG-115 Alone or with Azacitidine in R/R AML, CMML, MDS

NCT04358393Phase 2

Key facts

Status
Recruiting
Start
Dec 2020
Primary completion
Dec 2024
Countries
1
Modality
Small Molecules
Conditions
acute myeloid leukemia (AML)chronic myelomonocytic leukemia (CMML)myelodysplastic syndrome (MDS)
01

Overview

Phase 2, open-label trial of alrizomadlin in acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML) and myelodysplastic syndrome (MDS) (2 arms), sponsored by Ascentage Pharma. Primary endpoint: Maximum Tolerated Dose at 28 days. Started Dec 2020; status: recruiting.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • APG-115 Monotherapy

    APG-115 alone

  • APG-115 + Azacitidine

    APG-115 combined with Azacitidine

03

Who it enrols

Patients with relapsed or refractory AML, CMML, or high-risk MDS who have exhausted standard therapies, with adequate organ function and no active CNS leukemia or recent stem cell transplant.

04

Endpoints

Primary

  • Maximum Tolerated Dose

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