B-Cell Malignancies
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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