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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06179511




Registration number
NCT06179511
Ethics application status
Date submitted
27/10/2023
Date registered
22/12/2023
Date last updated
27/06/2024

Titles & IDs
Public title
Study of AZD9829 in CD123+ Hematological Malignancies
Scientific title
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
Secondary ID [1] 0 0
D9470C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematological Malignancies 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD9829

Experimental: Module 1: Dose Escalation - Ascending dose level cohorts of AZD9829 in AML and MDS participants.


Treatment: Drugs: AZD9829
AZD9829 will be administered by IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of dose limiting toxicities (DLTs).
Timepoint [1] 0 0
Module 1 - 28 days.
Primary outcome [2] 0 0
Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timepoint [2] 0 0
Module 1 - From informed consent until 30 days after last dose of AZD9829.
Secondary outcome [1] 0 0
Pharmacokinetics of AZD9829: Plasma Concentration of total antibody
Timepoint [1] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [2] 0 0
Pharmacokinetics of AZD9829: Plasma Concentration of total unconjugated warhead
Timepoint [2] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [3] 0 0
Pharmacokinetics of AZD9829: Area under the concentration time curve (AUC).
Timepoint [3] 0 0
Module 1 - From date of first dose of AZD9829up until 30 days post last dose.
Secondary outcome [4] 0 0
Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax).
Timepoint [4] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [5] 0 0
Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)
Timepoint [5] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [6] 0 0
Pharmacokinetics of AZD9829: Clearance
Timepoint [6] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [7] 0 0
Pharmacokinetics of AZD9829: Half-life (t 1/2)
Timepoint [7] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [8] 0 0
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Timepoint [8] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [9] 0 0
Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)
Timepoint [9] 0 0
Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.
Secondary outcome [10] 0 0
To determine the immunogenicity of AZD9829.
Timepoint [10] 0 0
Module 1 - From first dose to approximately 1 year.
Secondary outcome [11] 0 0
To determine the immunogenicity of AZD9829.
Timepoint [11] 0 0
Module 1 - From first dose to approximately 1 year.
Secondary outcome [12] 0 0
Overall Response Rate (ORR)
Timepoint [12] 0 0
Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year)
Secondary outcome [13] 0 0
Composite Complete Response Rate (CCRR)
Timepoint [13] 0 0
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Secondary outcome [14] 0 0
Complete remission with incomplete hematologic recovery (CRi)
Timepoint [14] 0 0
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Secondary outcome [15] 0 0
Complete Response (CR)
Timepoint [15] 0 0
Module 1 - From first dose of AZD9829 up to approximately 1 year.
Secondary outcome [16] 0 0
Duration of Response (DoR)
Timepoint [16] 0 0
Module 1 -Time from first documented response until disease progression or death (approximately 1 year).
Secondary outcome [17] 0 0
Time to Response (TTR)
Timepoint [17] 0 0
Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).
Secondary outcome [18] 0 0
Time to Next Treatment (TTNT)
Timepoint [18] 0 0
Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).
Secondary outcome [19] 0 0
Progression-free Survival (PFS)
Timepoint [19] 0 0
Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).
Secondary outcome [20] 0 0
Overall Survival (OS)
Timepoint [20] 0 0
Module 1 - From first dose of AZD9829 until death (approximately 1 year).
Secondary outcome [21] 0 0
Event-free Survival (EFS)
Timepoint [21] 0 0
Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/08/2026
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
VIC 3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
China
State/province [8] 0 0
Guangzhou
Country [9] 0 0
China
State/province [9] 0 0
Tianjian
Country [10] 0 0
Germany
State/province [10] 0 0
Frankfurt
Country [11] 0 0
Italy
State/province [11] 0 0
Bologna
Country [12] 0 0
Japan
State/province [12] 0 0
Kashiwa
Country [13] 0 0
Japan
State/province [13] 0 0
Osaka-shi
Country [14] 0 0
Japan
State/province [14] 0 0
Yoshida-gun
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Salamanca
Country [18] 0 0
Taiwan
State/province [18] 0 0
Tainan
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT06179511
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06179511