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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
Date last updated
6/11/2024

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 (TITANium)
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 hospital [2] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
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
Japan
State/province [19] 0 0
Kashiwa
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
L'Hospitalet de Llobregat
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
Trial website
https://clinicaltrials.gov/study/NCT06542250
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06542250