HER2 Expressing Tumors
Conditions
Brief summary
Objective Response Rate (ORR) according to RECIST v1.1, as assessed by investigator
Detailed description
Based on RECIST 1.1, as assessed by Investigator: 1) Duration of response (DoR)., Disease control rate (DCR)., Progression free survival (PFS)., Proportion of patients alive and progression-free at 3 monthly intervals staring from 6 months., Overall survival (OS)., Proportion of patients alive at 3 monthly intervals staring from 6 months, Occurrence of adverse events (AEs) and serious adverse events (SAEs)., Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181., The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd.
Interventions
DRUGDS-8201a
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) according to RECIST v1.1, as assessed by investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Based on RECIST 1.1, as assessed by Investigator: 1) Duration of response (DoR)., Disease control rate (DCR)., Progression free survival (PFS)., Proportion of patients alive and progression-free at 3 monthly intervals staring from 6 months., Overall survival (OS)., Proportion of patients alive at 3 monthly intervals staring from 6 months, Occurrence of adverse events (AEs) and serious adverse events (SAEs)., Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181., The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd. | — |
Countries
Italy, Poland, Spain
Outcome results
None listed