Study of AZD9829 in CD123+ Hematological Malignancies

April 17, 2024 updated by: AstraZeneca

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Heidelberg, Australia, 3084
        • Not yet recruiting
        • Research Site
      • Melbourne, Australia, VIC 3000
        • Recruiting
        • Research Site
  • China
      • Tianjian, China, 300020
        • Not yet recruiting
        • Research Site
  • Germany
      • Frankfurt, Germany, 60590
        • Not yet recruiting
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Research Site
  • Japan
      • Kashiwa, Japan, 227-8577
        • Not yet recruiting
        • Research Site
      • Osaka-shi, Japan, 545-8586
        • Recruiting
        • Research Site
      • Yoshida-gun, Japan, 910-1193
        • Recruiting
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Research Site
      • Salamanca, Spain, 37007
        • Not yet recruiting
        • Research Site
  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Research Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Not yet recruiting
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Module 1: Dose Escalation
Ascending dose level cohorts of AZD9829 in AML and MDS participants.
Drug: AZD9829
AZD9829 will be administered by IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of dose limiting toxicities (DLTs).
Time Frame: Module 1 - 28 days.
DLTs are dose-limiting toxicities as defined in the study protocol.
Module 1 - 28 days.
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
Module 1 - From informed consent until 30 days after last dose of AZD9829.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of AZD9829: Plasma Concentration of total antibody
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Measurement of plasma concentration of conjugated and unconjugated antibody
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Plasma Concentration of total unconjugated warhead
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Measurement of plasma concentration of total unconjugated warhead
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Area under the concentration time curve (AUC).
Time Frame: Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
Area under the plasma concentration-time curve.
Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax).
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Maximum observed plasma concentration of AZD9829.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Time to maximum observed plasma concentration of the study drug.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Clearance
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
The volume of plasma from which the study drug is completely removed per unit time.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Half-life (t 1/2)
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Terminal elimination half-life.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Evaluating the number of patients who develop anti-drug antibodies (ADA) during treatment.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Time Frame: Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Evaluating the percentage of patients who develop anti-drug antibodies (ADA) during treatment.
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
To determine the immunogenicity of AZD9829.
Time Frame: Module 1 - From first dose to approximately 1 year.
The number of participants who develop ADA (Anti Drug Antibodies).
Module 1 - From first dose to approximately 1 year.
To determine the immunogenicity of AZD9829.
Time Frame: Module 1 - From first dose to approximately 1 year.
The percentage of participants who develop ADA (Anti Drug Antibodies).
Module 1 - From first dose to approximately 1 year.
Overall Response Rate (ORR)
Time Frame: Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year)
Overall response rate disease assessments in accordance with ELN2022 recommendations for AML and IWG2018 for MDS.
Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year)
Composite Complete Response Rate (CCRR)
Time Frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Composite CR rate disease assessment in accordance with ELN2022 for AML and IWG2018 for MDS.
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete remission with incomplete hematologic recovery (CRi)
Time Frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
The endpoint of complete remission with CRi as defined by ELN2022 criteria.
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete Response (CR)
Time Frame: Module 1 - From first dose of AZD9829 up to approximately 1 year.
Complete response (CR) according to ELN2022 for AML and IWG2018 for MDS.
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Duration of Response (DoR)
Time Frame: Module 1 -Time from first documented response until disease progression or death (approximately 1 year).
Time from first documented response until the date of relapse or death.
Module 1 -Time from first documented response until disease progression or death (approximately 1 year).
Time to Response (TTR)
Time Frame: Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).
Time from first dose to the achievement of first overall response. Disease assessments will follow ELN2022 for AML and IWG2018 for MDS.
Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).
Time to Next Treatment (TTNT)
Time Frame: Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).
The time from the start of treatment date until the date of subsequent antileukemia therapy.
Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).
Progression-free Survival (PFS)
Time Frame: Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).
The time from the start of treatment date until the date of disease progression or death.
Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).
Overall Survival (OS)
Time Frame: Module 1 - From first dose of AZD9829 until death (approximately 1 year).
The time from the start of treatment date until death.
Module 1 - From first dose of AZD9829 until death (approximately 1 year).
Event-free Survival (EFS)
Time Frame: Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).
The time from the start of treatment date to disease progression, death, or initiation of a new anti-leukemic therapy.
Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Estimated)

August 4, 2026

Study Completion (Estimated)

August 4, 2026

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9470C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematological Malignancies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe