AZD9829 for Blood Cancers

Recruiting at 23 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants

Disqualifiers: CNS leukemia, Other malignancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

104 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

My blood cancer tests positive for CD123.

My condition is relapsed or refractory AML.

My bone marrow has at least 5% cancer cells.

Exclusion Criteria

I have had cancer before, but it might not affect my eligibility.

I have no severe side effects from previous treatments.

I have leukemia that has spread to my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Ascending dose level cohorts of AZD9829 in AML and MDS participants to determine safety and tolerability

4 weeks

Dose Optimization

Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants

Approximately 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD9829

Trial Overview 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.

Participant Groups

Group I: Module 1: Dose Optimization Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology