Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2024-01-31
2027-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 1: Dose Escalation
Ascending dose level cohorts of AZD9829 in AML and MDS participants.
AZD9829
AZD9829 will be administered by IV infusion
Module 1: Dose Optimization
Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during dose escalation, dose optimization and backfill.
AZD9829
AZD9829 will be administered by IV infusion
Interventions
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AZD9829
AZD9829 will be administered by IV infusion
AZD9829
AZD9829 will be administered by IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Duarte, California, United States
Research Site
St Louis, Missouri, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Houston, Texas, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Heidelberg, , Australia
Research Site
Melbourne, , Australia
Research Site
Guangzhou, , China
Research Site
Tianjin, , China
Research Site
Zhengzhou, , China
Research Site
Frankfurt, , Germany
Research Site
Bologna, , Italy
Research Site
Kashiwa, , Japan
Research Site
Osaka, , Japan
Research Site
Yoshida-gun, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Salamanca, , Spain
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D9470C00001
Identifier Type: -
Identifier Source: org_study_id
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