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Completed

NCT Number: NCT06179511

Study of AZD9829 in CD123+ 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.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Heidelberg, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

AZD9829

Drug

AZD9829 will be administered by IV infusion

Primary outcomes

  1. Frequency of dose limiting toxicities (DLTs).

    Time frame: Module 1 - 28 days.

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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

    Measurement of plasma concentration of conjugated and unconjugated antibody

  2. 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.

    Measurement of plasma concentration of total unconjugated warhead

  3. 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.

    Area under the plasma concentration-time curve.

  4. 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.

    Maximum observed plasma concentration of AZD9829.

  5. 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.

    Time to maximum observed plasma concentration of the study drug.

  6. Pharmacokinetics of AZD9829: Clearance

    Time frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.

    The volume of plasma from which the study drug is completely removed per unit time.

  7. 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.

    Terminal elimination half-life.

  8. 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.

    Evaluating the number of patients who develop anti-drug antibodies (ADA) during treatment.

  9. 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.

    Evaluating the percentage of patients who develop anti-drug antibodies (ADA) during treatment.

  10. To determine the immunogenicity of AZD9829.

    Time frame: Module 1 - From first dose to the 30-Day SFU visit

    The number of participants who develop ADA (Anti Drug Antibodies).

  11. To determine the immunogenicity of AZD9829.

    Time frame: Module 1 - From first dose to the 30-Day SFU visit

    The percentage of participants who develop ADA (Anti Drug Antibodies).

  12. 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)

    Overall response rate disease assessments in accordance with ELN2022 recommendations for AML and IWG 2006/2018 for MDS.

  13. Composite Complete Response Rate (CCRR)

    Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.

    Composite CR rate disease assessment in accordance with ELN2022 for AML and IWG 2006/2018 for MDS.

  14. Complete remission with incomplete hematologic recovery (CRi)

    Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.

    The endpoint of complete remission with CRi as defined by ELN2022 criteria.

  15. Complete Response (CR)

    Time frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.

    Complete response (CR) according to ELN2022 for AML and IWG 2006/2018 for MDS.

  16. Duration of Response (DoR)

    Time frame: Module 1 -Time from first documented response until disease progression or death (approximately 1 year).

    Time from first documented response until the date of relapse or death.

  17. Time to Response (TTR)

    Time frame: Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).

    Time from first dose to the achievement of first overall response. Disease assessments will follow ELN2022 for AML and IWG 2006/2018 for MDS.

  18. 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).

    The time from the start of treatment date until the date of subsequent antileukemia therapy.

  19. Progression-free Survival (PFS)

    Time frame: Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).

    The time from the start of treatment date until the date of disease progression or death.

  20. Overall Survival (OS)

    Time frame: Module 1 - From first dose of AZD9829 until death (approximately 1 year).

    The time from the start of treatment date until death.

  21. 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).

    The time from the start of treatment date to disease progression, death, or initiation of a new anti-leukemic therapy.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 22, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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