Study of AZD9829 in CD123+ Hematological Malignancies

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

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.

Inclusion Criteria:

• ≥18 years of age;

• CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;

  • R/R AML (except APL);
  • R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;

• Had at least 1 prior line of therapy at currents histology, and have no available treatment options;

• ECOG performance status of ≤ 2.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

• Active CNS leukemia;
• Previous treatment with any CD123 targeting therapy;
• Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
• Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
• History of other malignancy(with certain exceptions);
• Active and uncontrolled infections;
• Unresolved AEs ≥2 Grade, from prior therapies.

The above is a summary, other exclusion criteria details may apply .