Study of AZD9829 in CD123+ Hematological Malignancies
Research type
Research Study
Full title
A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients with CD123-Positive Hematological Malignancies
IRAS ID
1010391
Contact name
Yehan Wijesinghe
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
This is a Phase I/II open-label study, where researchers will learn if AZD9829 is safe and works alone or in combination with other treatments for blood cancers that are CD123-positive. This study has a modular design, meaning, that the study may have multiple trial parts that
can be added with different characteristics. This study currently comprises one module, with 2 parts. Part A (dose escalation) involves 6 participant groups receiving increasing dose levels. Safety results are assessed after each group receives their dose to see if the next dose level is safe for the next group. In Part B (dose optimization), the best doses from part A will be given to all participants randomly,
and researchers will learn more about these doses and find the best dose to continue treating patients.The study population include in the current module comprises relapse-refractory patients with acute myeloid leukemia (R/R AML) and R/R high-risk myelodysplastic syndrome (HR-MDS) that express any level of CD123, with more than 1 line of treatment and no available treatment options. Leukemia and MDS are a type of blood cancer that affects bone marrow and blood.
The trial drug, AZD9829, works in a two-step process. The first step is to target the cells that have CD123 proteins, and the second step is to deliver a cell-killing drug directly inside these cells. AZD9829 will be given through a needle into the vein (IV infusion) in cycles of 28 days. Participants will be monitored throughout the study for safety and to check whether the treatment is working. This trial will have up to 132 participants from UK, US, Australia, Asia, and Europe.
All participants will help researchers learn more about AZD9829 and CD123-positive blood cancers whilst potentially benefiting from improvement of their disease.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0130
Date of REC Opinion
17 Sep 2024
REC opinion
Further Information Favourable Opinion