Study of AZD9829 in CD123+ Hematological Malignancies

AstraZeneca

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Hematological Malignancies

Treatments: Drug: AZD9829

Study type: Interventional

Funder types: Industry

Identifiers

NCT06179511

D9470C00001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Module 1: Dose Escalation

Experimental group

Description:

Ascending dose level cohorts of AZD9829 in AML and MDS participants.

Treatment:

Drug: AZD9829

Drug: AZD9829

Module 1: Dose Optimization

Experimental group

Description:

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.

Treatment:

Drug: AZD9829

Drug: AZD9829