LA/mGC/GEJC (locally advanced unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma, collectively) and LA/mBC (locally advanced metastatic breast cancer)
Conditions
Brief summary
Incidence of dose-limiting toxicities (DLTs) in dose escalation phase, Type, incidence, severity, seriousness, and relatedness of AEs, Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline, Frequency of treatment interruptions, dose reductions, and treatment discontinuations due to AEs, ORR (confirmed complete response [CR] and confirmed partial response [PR]) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Detailed description
Duration of response (DOR) per RECIST v1.1 by investigator assessment, Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment, Progression-free survival (PFS) per RECIST v1.1 by investigator assessment, Overall Survival (OS), Estimates of selected PK parameters of disitamab vedotin, total antibody, and unconjugated MMAE, Incidence of anti-drug antibodies (ADA) against disitamab vedotin
Interventions
Sponsors
Seagen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) in dose escalation phase, Type, incidence, severity, seriousness, and relatedness of AEs, Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline, Frequency of treatment interruptions, dose reductions, and treatment discontinuations due to AEs, ORR (confirmed complete response [CR] and confirmed partial response [PR]) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) per RECIST v1.1 by investigator assessment, Disease control rate (DCR) (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1 by investigator assessment, Progression-free survival (PFS) per RECIST v1.1 by investigator assessment, Overall Survival (OS), Estimates of selected PK parameters of disitamab vedotin, total antibody, and unconjugated MMAE, Incidence of anti-drug antibodies (ADA) against disitamab vedotin | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed