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AZD9829

Phase 1

Hematological Malignancies | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 1, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

AZD9829 · 1 trial · 1 indication

Phase 1 1
NCT06179511Study of AZD9829 in CD123+ Hematological MalignanciesHematological Malignancies
COMPLETED56 Analytics
PHASE1COMPLETED
Study of AZD9829 in CD123+ Hematological Malignancies
Hematological MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of dose limiting toxicities (DLTs).
Module 1 - 28 days.

DLTs are dose-limiting toxicities as defined in the study protocol.

Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Module 1 - From informed consent until 60 days after last dose of AZD9829.

Frequency, severity and relationship to study drug of AEs and SAEs

Identify RP2D in R/R AML patients.
Moldule 1 -From informed consent until 60 days after last dose of AZD9829.

Incidence of AEs/SAEs and PK data

Secondary Endpoints

Pharmacokinetics of AZD9829: Plasma Concentration of total antibody
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Plasma Concentration of total unconjugated warhead
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Area under the concentration time curve (AUC).
Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1: Dose EscalationEXPERIMENTALAscending dose level cohorts of AZD9829 in AML and MDS participants.
Module 1: Dose OptimizationEXPERIMENTALCharacterizing 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.

Interventions

NameTypeDescription
AZD9829DRUGAZD9829 will be administered by IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

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 h...

Countries:United StatesAustraliaChinaGermanyItalyJapanSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 1, 2026NCT06179511TRIAL_REMOVED: changed
MEDIUMAug 1, 2026NCT06179511TRIAL_REMOVED: changed
MEDIUMAug 1, 2026NCT06179511TRIAL_REMOVED: changed
HIGHJul 2, 2026NCT06179511Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 2, 2026NCT06179511Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 2, 2026NCT06179511Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 2, 2026NCT06179511Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about AZD9829

What is AZD9829 used for?

AZD9829 is an investigational small molecule being developed for the treatment of hematological malignancies, which are cancers of the blood and bone marrow. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does AZD9829 target?

AZD9829 is designed to target CD123, a protein expressed on the surface of certain cells in hematological malignancies. By targeting CD123, the drug aims to interfere with the growth and survival of cancer cells in these blood cancers.

Who makes AZD9829?

AZD9829 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is AZD9829 in?

AZD9829 is in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with CD123-positive hematological malignancies. The drug is investigational and has not received regulatory approval.

What clinical trials is AZD9829 in?

AZD9829 is being studied in a Phase 1 clinical trial registered as NCT06179511, titled 'Study of AZD9829 in CD123+ Hematological Malignancies.' This completed trial enrolled 56 participants across multiple countries, including the United States, Australia, China, Germany, Italy, Japan, South Korea, Spain, Taiwan, and the United Kingdom.

Is AZD9829 the same as any other drug?

AZD9829 is a unique investigational compound developed by AstraZeneca. It is not known to have any alternative names or to be the same as any other approved or investigational drug. Its distinct chemical structure and target differentiate it from other therapies in development.