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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06542250




Registration number
NCT06542250
Ethics application status
Date submitted
29/07/2024
Date registered
7/08/2024

Titles & IDs
Public title
A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.
Scientific title
A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies
Secondary ID [1] 0 0
D9960C00001
Universal Trial Number (UTN)
Trial acronym
TITANium
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Malignancies 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD5492

Experimental: Module 1: AZD5492 Monotherapy - AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.


Treatment: Drugs: AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
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 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
Primary outcome [2] 0 0
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.
Timepoint [2] 0 0
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Primary outcome [3] 0 0
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.
Timepoint [3] 0 0
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Module 1 - From first dose of AZD5492 up to approximately 2 years.
Secondary outcome [2] 0 0
Complete Response Rate (CR Rate)
Timepoint [2] 0 0
Module 1 - From first dose of AZD5492 up to approximately 2 years.
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
Module 1 - From first dose of AZD5492 up to approximately 2 years.
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
Module 1 - From first dose of AZD5492 up to approximately 2 years.
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Module 1 - From first dose of AZD5492 up to approximately 2 years.
Secondary outcome [6] 0 0
Pharmacokinetics of AZD5492: serum concentration of study drug
Timepoint [6] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [7] 0 0
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).
Timepoint [7] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [8] 0 0
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).
Timepoint [8] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [9] 0 0
Pharmacokinetics of AZD5492: apparent clearance
Timepoint [9] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [10] 0 0
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Timepoint [10] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [11] 0 0
To determine the immunogenicity of AZD5492
Timepoint [11] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Secondary outcome [12] 0 0
To determine the immunogenicity of AZD5492
Timepoint [12] 0 0
Module 1 - From informed consent until 90 days after last dose of AZD5492.

Eligibility
Key inclusion criteria
* =18 years of age;
* Histologically documented CD20+ mature B-cell neoplasm

* Large B-cell lymphoma
* Follicular lymphoma
* Mantle cell lymphoma
* Chronic lymphocytic leukemia
* Small lymphocytic lymphoma
* Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
* 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 involvement in lymphoma or CNS pathology;
* Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or Burkitt-like lymphoma;
* Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
* History of Grade = 3 CRS or Grade = 3 ICANS;
* Active and uncontrolled infections;
* Unresolved AEs =2 Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
18/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/02/2028
Actual
Sample size
Target
174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
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
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
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
Washington
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Denmark
State/province [11] 0 0
København Ø
Country [12] 0 0
France
State/province [12] 0 0
Pessac
Country [13] 0 0
Germany
State/province [13] 0 0
München
Country [14] 0 0
Germany
State/province [14] 0 0
Ulm
Country [15] 0 0
Germany
State/province [15] 0 0
Wuerzburg
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Japan
State/province [18] 0 0
Chuo-ku
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
L'Hospitalet de Llobregat
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid

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

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/.

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

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/.
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.vivli.org


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/NCT06542250