Hematological MalignanciesPhase 1/2NCT06179511
Study of AZD9829 in CD123+ Hematological Malignancies
A Phase 1/2 study testing AZD9829 in people with Hematological Malignancies, run by AstraZeneca at 22 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- AZD9829
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 22 sitesin 10 countries
- Study dates
- 31 Jan 2024to 24 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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 .
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
United States7 sites
Research Site
Chapel Hill, North Carolina, 27514
Research Site
Columbus, Ohio, 43210
Research Site
Duarte, California, 91010
Research Site
Houston, Texas, 77030
Research Site
Milwaukee, Wisconsin, 53226
Research Site
New York, New York, 10021
Research Site
St Louis, Missouri, 63110
Japan3 sites
Research Site
Kashiwa, 227-8577
Research Site
Osaka, 545-8586
Research Site
Yoshida-gun, 910-1193
Australia2 sites
Research Site
Heidelberg, 3084
Research Site
Melbourne, VIC 3000
About this study
Official title: 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.
- Conditions
- Hematological Malignancies
- Being tested
- AZD9829
- Keywords
- AZD9829, Anti-cancer agents, Dose escalation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9829Drug
AZD9829 will be administered by IV infusion
AZD9829Drug
AZD9829 will be administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Module 1: Dose Escalation | Experimental | Ascending dose level cohorts of AZD9829 in AML and MDS participants. Receives: Drug: AZD9829 |
| Module 1: Dose Optimization | Experimental | 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. Receives: Drug: AZD9829 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dose limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
Measured: Module 1 - 28 days.
Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Frequency, severity and relationship to study drug of AEs and SAEs
Measured: Module 1 - From informed consent until 60 days after last dose of AZD9829.
Identify RP2D in R/R AML patients.
Incidence of AEs/SAEs and PK data
Measured: Moldule 1 -From informed consent until 60 days after last dose of AZD9829.
Secondary outcomes (21)
Pharmacokinetics of AZD9829: Plasma Concentration of total antibody
Measurement of plasma concentration of conjugated and unconjugated antibody
Measured: 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
Measurement of plasma concentration of total unconjugated warhead
Measured: 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).
Area under the plasma concentration-time curve.
Measured: Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD9829.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)
Time to maximum observed plasma concentration of the study drug.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Clearance
The volume of plasma from which the study drug is completely removed per unit time.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Half-life (t 1/2)
Terminal elimination half-life.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Evaluating the number of patients who develop anti-drug antibodies (ADA) during treatment.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Evaluating the percentage of patients who develop anti-drug antibodies (ADA) during treatment.
Measured: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
To determine the immunogenicity of AZD9829.
The number of participants who develop ADA (Anti Drug Antibodies).
Measured: Module 1 - From first dose to the 30-Day SFU visit
To determine the immunogenicity of AZD9829.
The percentage of participants who develop ADA (Anti Drug Antibodies).
Measured: Module 1 - From first dose to the 30-Day SFU visit
Overall Response Rate (ORR)
Overall response rate disease assessments in accordance with ELN2022 recommendations for AML and IWG 2006/2018 for MDS.
Measured: Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year)
Composite Complete Response Rate (CCRR)
Composite CR rate disease assessment in accordance with ELN2022 for AML and IWG 2006/2018 for MDS.
Measured: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete remission with incomplete hematologic recovery (CRi)
The endpoint of complete remission with CRi as defined by ELN2022 criteria.
Measured: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete Response (CR)
Complete response (CR) according to ELN2022 for AML and IWG 2006/2018 for MDS.
Measured: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Duration of Response (DoR)
Time from first documented response until the date of relapse or death.
Measured: Module 1 -Time from first documented response until disease progression or death (approximately 1 year).
Time to Response (TTR)
Time from first dose to the achievement of first overall response. Disease assessments will follow ELN2022 for AML and IWG 2006/2018 for MDS.
Measured: Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).
Time to Next Treatment (TTNT)
The time from the start of treatment date until the date of subsequent antileukemia therapy.
Measured: Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).
Progression-free Survival (PFS)
The time from the start of treatment date until the date of disease progression or death.
Measured: Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).
Overall Survival (OS)
The time from the start of treatment date until death.
Measured: Module 1 - From first dose of AZD9829 until death (approximately 1 year).
Event-free Survival (EFS)
The time from the start of treatment date to disease progression, death, or initiation of a new anti-leukemic therapy.
Measured: Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start31 Jan 2024
- Primary completion31 Oct 2025
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179511
- Sponsor's protocol ID
- D9470C00001
- Status last verified
- Jun 2026
- First submitted
- 27 Oct 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06179511
- Acronym / sponsor ID
- D9470C00001
- Conditions
- Hematological Malignancies
- Keywords
- AZD9829, Anti-cancer agents, Dose escalation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module 1: Dose Escalation | Experimental | Drug: AZD9829Ascending dose level cohorts of AZD9829 in AML and MDS participants. |
| Module 1: Dose Optimization | Experimental | Drug: AZD9829Characterizing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age;
- CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9829AZD9829 will be administered by IV infusion | Drug | Module 1: Dose Escalation |
| AZD9829AZD9829 will be administered by IV infusion | Drug | Module 1: Dose Optimization |
Primary outcome
Frequency of dose limiting toxicities (DLTs).
Time frame: 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
Time frame: 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.
Time frame: Moldule 1 -From informed consent until 60 days after last dose of AZD9829.
Incidence of AEs/SAEs and PK data
21 secondary outcomes
Pharmacokinetics of AZD9829: Plasma Concentration of total antibody
Time frame: 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
Time frame: 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).
Time frame: Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax).
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Clearance
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Half-life (t 1/2)
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
To determine the immunogenicity of AZD9829.
Time frame: Module 1 - From first dose to the 30-Day SFU visit
To determine the immunogenicity of AZD9829.
Time frame: Module 1 - From first dose to the 30-Day SFU visit
Overall Response Rate (ORR)
Time frame: Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year)
Composite Complete Response Rate (CCRR)
Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete remission with incomplete hematologic recovery (CRi)
Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete Response (CR)
Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Duration of Response (DoR)
Time frame: Module 1 -Time from first documented response until disease progression or death (approximately 1 year).
Time to Response (TTR)
Time frame: Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).
Time to Next Treatment (TTNT)
Time frame: Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).
Progression-free Survival (PFS)
Time frame: Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).
Overall Survival (OS)
Time frame: Module 1 - From first dose of AZD9829 until death (approximately 1 year).
Event-free Survival (EFS)
Time frame: Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD9829 in people with Hematological Malignancies, run by AstraZeneca at 22 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Japan, Australia, South Korea, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dose limiting toxicities (DLTs). (time frame: Module 1 - 28 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.