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

JRCT ID: jRCT2051230181

Registered date:15/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hematological Malignancies
• Date of first enrollment: 31/01/2024
• Target sample size: 96
• Countries of recruitment: US,Japan,Australia,Japan,South Korea,Japan,Taiwan,Japan,Italy,Japan,Germany,Japan,Spain,Japan,China,Japan,France,Japan,UK,Japan
• Study type: Interventional
• Intervention(s): AZD9829 will be administered by IV infusion

Outcome(s)

Primary Outcome

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 30 days after last dose of AZD9829. ]
Frequency, severity and relationship to study drug of AEs and SAEs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 18 years of age or more ;

- CD123+hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;

- R/R AML;

- R/R HR-MDS with 5% or more 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 or less.

The above is a summary, other inclusion criteria details may apply.

Exclude 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 or more, from prior therapies.

The above is a summary, other exclusion criteria details may apply.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06179511