Skip to content

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)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511099-34-00
Acronym
TITANium
Enrollment
66
Registered
2024-10-25
Start date
2024-12-12
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Malignancies

Brief summary

Occurrence of Dose-Limiting Toxicities (DLTs), Incidence and severity of AEs, AESIs, and SAEs, SAEs/AEs leading to discontinuation of AZD5492, Clinically significant alterations in vital signs and abnormal laboratory parameters

Detailed description

Evaluate the preliminary antitumor activity of AZD5492 in participants with R/R B-cell malignancies, by looking at: - ORR (Overall Response Rate), CR Rate, DoR (duration of response), and PFS (progression free survival) according to Lugano criteria and iwCLL 2018 criteria; - OS (overall survival)., Characterize pharmacokinetics profile of AZD5492, by: - Determining PK parameters, including but not limited to Cmax (maximum observed concentration), AUC (Area under the curve), clearance and t½ (half-life). - Antibody serum concentration., Determine the immunogenicity of AZD5492: the number and percentage of participants who develop ADA (Anti Drug Antibodies).

Interventions

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of Dose-Limiting Toxicities (DLTs), Incidence and severity of AEs, AESIs, and SAEs, SAEs/AEs leading to discontinuation of AZD5492, Clinically significant alterations in vital signs and abnormal laboratory parameters

Secondary

MeasureTime frame
Evaluate the preliminary antitumor activity of AZD5492 in participants with R/R B-cell malignancies, by looking at: - ORR (Overall Response Rate), CR Rate, DoR (duration of response), and PFS (progression free survival) according to Lugano criteria and iwCLL 2018 criteria; - OS (overall survival)., Characterize pharmacokinetics profile of AZD5492, by: - Determining PK parameters, including but not limited to Cmax (maximum observed concentration), AUC (Area under the curve), clearance and t½ (half-life). - Antibody serum concentration., Determine the immunogenicity of AZD5492: the number and percentage of participants who develop ADA (Anti Drug Antibodies).

Countries

Denmark, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026