Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Brief summary
OS is defined as the time interval from the date of randomization to the date of death due to any cause.
Detailed description
PFS is defined as the time interval from the date of randomization to the first date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first., ORR is defined as the proportion of subjects with a BOR of confirmed CR or confirmed PR as assessed by BICR per RECIST v1.1., DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR), which is subsequently confirmed by BICR assessment, to the first documentation of objective tumor progression (confirmed by BICR) or to death due to any cause, whichever occurs first., DCR is defined as the proportion of subjects with a BOR of confirmed CR, confirmed PR, or SD according to RECIST v1.1 and will be determined by BICR assessment review of tumor scans., The following subscales from validated instruments will be used to assess PROs: EORTC QLQ-C30 – Global Health Status/Quality of Life scale, physical functioning, and fatigue EORTC OES18 – Dysphagia, trouble with eating, reflux, and pain Change in scores from baseline for each cycle up to Cycle 4 and Cycle 6 will be measured for each scale. In addition, TTD from baseline will be calculated using a deterioration score threshold of ≥10 points., Incidence of TEAEs, serious TEAEs, and AESIs graded according to the NCI‑CTCAE v5.0, including deaths, changes from baseline in vital signs, clinical laboratory results, ECGs, and ECHO/MUGA., ADA measured in plasma with a validated assay. ADA prevalence: The proportion of subjects who are ADA positive at any point in time (including pre existing ADA at baseline and treatment emergent ADA). ADA incidence: The proportion of subjects having treatment emergent ADA. Titer and neutralizing antibodies will be determined when the ADA is positive., B7-H3 protein expression in tumor tissue at baseline as determined by IHC and correlation with OS and other efficacy endpoints, Plasma concentrations at each time point and PK parameters (Cmax, Tmax, AUClast, and AUCtau) for I DXd, total anti B7-H3 antibody, and DXd in the full PK subset.
Interventions
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS is defined as the time interval from the date of randomization to the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is defined as the time interval from the date of randomization to the first date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first., ORR is defined as the proportion of subjects with a BOR of confirmed CR or confirmed PR as assessed by BICR per RECIST v1.1., DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR), which is subsequently confirmed by BICR assessment, to the first documentation of objective tumor progression (confirmed by BICR) or to death due to any cause, whichever occurs first., DCR is defined as the proportion of subjects with a BOR of confirmed CR, confirmed PR, or SD according to RECIST v1.1 and will be determined by BICR assessment review of tumor scans., The following subscales from validated instruments will be used to assess PROs: EORTC QLQ-C30 – Global Health Status/Quality of Life scale, physical functioning, and fatigue EORTC OES18 – Dysphagia, trou | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden
Outcome results
None listed