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Monoclonal Antibodies

AZD9829 for Blood Cancers

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

R/R AML

Must not have

Active CNS leukemia

Unresolved AEs ≥2 Grade, from prior therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up module 1 - from first dose of azd9829 up to approximately 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD9829. It will be given through a vein to patients with certain types of blood cancers. The study will determine the best dose of the drug to

Who is the study for?

This trial is for individuals with blood cancers that express a marker called CD123. Specific details about who can join or reasons why someone might not be eligible are not provided.

What is being tested?

The study is testing AZD9829, given through the vein either alone or with other treatments, to see how it works in treating various blood cancers marked by CD123.

What are the potential side effects?

Potential side effects of AZD9829 are not listed, but as with any cancer treatment, they may include reactions at the infusion site, fatigue, nausea, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood cancer tests positive for CD123.

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My condition is relapsed or refractory AML.

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My bone marrow has at least 5% cancer cells.

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I've had one treatment for my current cancer type and have no other treatment options.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have leukemia that has spread to my brain.

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I have no severe side effects from previous treatments.

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I have been treated with a therapy targeting CD123 before.

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I do not have any ongoing and untreated infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ module 1 - from first dose of azd9829 up to approximately 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~module 1 - from first dose of azd9829 up to approximately 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and module 1 - from first dose of azd9829 up to approximately 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of dose limiting toxicities (DLTs).

Identify RP2D in R/R AML patients.

Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary study objectives

Complete Response (CR)

Complete remission with incomplete hematologic recovery (CRi)

Composite Complete Response Rate (CCRR)

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module 1: Dose OptimizationExperimental Treatment1 Intervention

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.

Group II: Module 1: Dose EscalationExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met