Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644781
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study of Ifinatamab Deruxtecan in Subjects With Advanced or Metastatic ESCC IDeate-Esophageal01
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-label Study of Ifinatamab Deruxtecan I-DXd in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma ESCC IDeate-Esophageal01
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan I-DXd in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma ESCC who have experienced disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor ICI compared with investigators choice of chemotherapy ICC
Detailed Description:
The primary objective of this study is to evaluate the overall survival OS benefit of I-DXd compared with investigators choice of chemotherapy ICC
The key secondary objectives of the study will evaluate the progression-free survival PFS and objective response rate ORR benefit of I-DXd compared with ICC
The key secondary objectives of the study will evaluate the progression-free survival PFS and objective response rate ORR benefit of I-DXd compared with ICC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None