Study of AZD9829 in CD123+ Hematological Malignancies
Phase 1/2 – combined early trial
Conditions:
Hematological Malignancies
Sponsor: AstraZeneca
trial.available_in:
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Overview
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.
Who can participate
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 .
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