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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.

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.

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.

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Research Site

The study consists of individual modules each evaluating the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD5492 as monotherapy or in combination with other anticancer treatments in participants with R/R B-cell malignancies. 

- Module 1: AZD9592 Monotherapy

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)

DLTs are dose-limiting toxicities as defined in the study protocol.

Incidence and severity of AEs, AESIs, and SAEs

SAEs/AEs leading to discontinuation of AZD5492.

The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.

The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.

The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.

The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.

The time from the date of first dose until date of death due to any cause.

Maximum observed serum concentration of AZD5492.

Maximum observed plasma concentration of AZD5492.

Area under the plasma concentration-time curve.

The volume of plasma from which the study drug is completely removed per unit time.

The number of participants who develop ADAs measured in serum.

The percentage of participants who develop ADAs measured in serum.

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. - TITANium

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Estimated Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Contacts

Contact