NCT06179511

Brief Summary

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2024

Typical duration for phase_1

Geographic Reach
10 countries

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

October 27, 2023

Last Update Submit

January 27, 2026

Conditions

Hematological Malignancies

Keywords

AZD9829Anti-cancer agentsDose escalation

Outcome Measures

Primary Outcomes (3)

  • Frequency of dose limiting toxicities (DLTs).

    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

    Frequency, severity and relationship to study drug of AEs and SAEs

    Module 1 - From informed consent until 60 days after last dose of AZD9829.

  • Identify RP2D in R/R AML patients.

    Incidence of AEs/SAEs and PK data

    Moldule 1 -From informed consent until 60 days after last dose of AZD9829.

Secondary Outcomes (21)

  • Pharmacokinetics of AZD9829: Plasma Concentration of total 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

    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).

    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).

    Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.

  • Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)

    Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.

  • +16 more secondary outcomes

Study Arms (2)

Module 1: Dose Escalation

EXPERIMENTAL

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

Drug: AZD9829

Module 1: Dose Optimization

EXPERIMENTAL

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.

Drug: AZD9829

Interventions

AZD9829DRUG

AZD9829 will be administered by IV infusion

Module 1: Dose Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age;
  • CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
  • R/R AML (except APL);
  • Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
  • ECOG performance status of ≤ 2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Research Site

Duarte, California, 91010, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

New York, New York, 10021, United States

Location

Research Site

Chapel Hill, North Carolina, 27514, United States

Location

Research Site

Columbus, Ohio, 43210, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Milwaukee, Wisconsin, 53226, United States

Location

Research Site

Heidelberg, 3084, Australia

Location

Research Site

Melbourne, VIC 3000, Australia

Location

Research Site

Tianjin, 300020, China

Location

Research Site

Frankfurt, 60590, Germany

Location

Research Site

Bologna, 40138, Italy

Location

Research Site

Kashiwa, 227-8577, Japan

Location

Research Site

Osaka, 545-8586, Japan

Location

Research Site

Yoshida-gun, 910-1193, Japan

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Salamanca, 37007, Spain

Location

Research Site

Tainan, 704, Taiwan

Location

Research Site

Taipei, 10002, Taiwan

Location

Research Site

Manchester, M204BX, United Kingdom

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

December 22, 2023

Study Start

January 31, 2024

Primary Completion

October 31, 2025

Study Completion

March 23, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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
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.
More information

Locations

AU(2)KR(2)DE(1)IT(1)GB(1)US(7)TW(2)ES(2)JP(3)CN(1)