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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

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
Treatment: Drugs - AZD9829

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

Experimental: Module 1: Dose Optimization - 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.


Treatment: Drugs: AZD9829
AZD9829 will be administered by IV infusion

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.
Primary outcome [3] 0 0
Identify RP2D in R/R AML patients.
Timepoint [3] 0 0
Moldule 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
Non-randomised trial
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
27/04/2027
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
Tianjin
Country [10] 0 0
China
State/province [10] 0 0
Zhengzhou
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Japan
State/province [13] 0 0
Kashiwa
Country [14] 0 0
Japan
State/province [14] 0 0
Osaka-shi
Country [15] 0 0
Japan
State/province [15] 0 0
Yoshida-gun
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Salamanca
Country [19] 0 0
Taiwan
State/province [19] 0 0
Tainan
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06179511