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AZD9829

Phase 1

Hematological Malignancies | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06179511Study of AZD9829 in CD123+ Hematological MalignanciesPHASE1 ACTIVE NOT_RECRUITING 56 — — Jan 31, 2024Mar 23, 2026Jan 29, 202622 United States, Australia +8
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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 — 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)
LOWMay 26, 2026NCT06179511primaryCompletionDate: changed
LOWMay 24, 2026NCT06179511studyFirstPostDate: changed