Metastatic Solid Tumor, Advanced Solid Tumor
Conditions
Brief summary
Dose-limiting Toxicities (DLTs) [Part 1 only], Treatmentemergent Adverse Events (TEAEs), Laboratory findings, electrocardiogram (ECG), vital signs, echocardiogram or multigated acquisition (ECHO/MUGA) findings, physical examination results, Objective Response Rate (ORR) [Part 2 only]
Detailed description
Objective Response Rate (ORR) [Part 1 only], Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), Progression Free Survival (PFS), Overall Survival (OS), TA-MUC1 Expression by Immunohistochemistry (IHC), Plasma PK parameters (eg, AUClast, AUCtau, Cmax, Tmax, Ctrough, and t1/2) of total conjugated payload, total anti-TAMUC1 antibody, and free payload, Anti-drug Antibodies (ADAs) for DS-3939a (status and titers) at Baseline and on treatment
Interventions
DRUGDS-3939a
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting Toxicities (DLTs) [Part 1 only], Treatmentemergent Adverse Events (TEAEs), Laboratory findings, electrocardiogram (ECG), vital signs, echocardiogram or multigated acquisition (ECHO/MUGA) findings, physical examination results, Objective Response Rate (ORR) [Part 2 only] | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) [Part 1 only], Disease Control Rate (DCR), Duration of Response (DoR), Time to Response (TTR), Progression Free Survival (PFS), Overall Survival (OS), TA-MUC1 Expression by Immunohistochemistry (IHC), Plasma PK parameters (eg, AUClast, AUCtau, Cmax, Tmax, Ctrough, and t1/2) of total conjugated payload, total anti-TAMUC1 antibody, and free payload, Anti-drug Antibodies (ADAs) for DS-3939a (status and titers) at Baseline and on treatment | — |
Countries
Belgium, France, Spain
Outcome results
None listed