Treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology
Conditions
Brief summary
Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR).
Detailed description
1) Duration of response (DoR) based on ICR assessment., 2) Disease control rate (DCR) based on ICR assessment., 3) Progression free survival (PFS) based on ICR assessment., 4) Confirmed Objective Response Rate (ORR) based on investigator assessment., 5) Overall survival (OS)., 6) Occurrence of adverse events (AEs) and serious adverse events (SAEs)., 7) Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181., 8) 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 |
|---|---|
| Confirmed objective response rate by RECIST v1.1 based on independent central review (ICR). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Duration of response (DoR) based on ICR assessment., 2) Disease control rate (DCR) based on ICR assessment., 3) Progression free survival (PFS) based on ICR assessment., 4) Confirmed Objective Response Rate (ORR) based on investigator assessment., 5) Overall survival (OS)., 6) Occurrence of adverse events (AEs) and serious adverse events (SAEs)., 7) Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181., 8) The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd. | — |
Countries
Denmark, France
Outcome results
None listed