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RecruitingLast updated: 9 August 2024

This study is evaluating a new drug (called AZD9829) in people with CD123 positive blood cancersA 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

Clinical summary

Summary

This is a modular dose-setting study. AZD9829 will be administered intravenously (via IV) by itself or in combination with other treatments. Module 1 (Dose Escalation) will involve ascending dose level cohorts of AZD9829 in AML and MDS participants.

Conditions

This trial is treating patients with relapsed or refractory haematological malignancies, including acute myeloid leukaemia and high risk myelodysplastic syndromes

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • ≥18 years of age;
  • CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;

    • R/R AML;
    • 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

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Information for family, friends and carers

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