Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248515
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-31
Brief Title:
A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Phase II Parallel Arm Study of SACITUZUMAB GOVITECAN-HZIY in Patients With Advanced Thymoma and Thymic Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to study the effect of sacituzumab govitecan-hziy in adult patients with advanced thymoma and thymic carcinoma after progressing on at least one prior line of therapy
The main question it aims to answer is
What is the overall response rate ORR in patients with advanced thymoma and thymic carcinoma
Participants will
receive a fixed dose of 10 mgkg given intravenously once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity
have regular blood tests scans and examinations to monitor their health
have blood and a biopsy of their tumor for research purposes
The main question it aims to answer is
What is the overall response rate ORR in patients with advanced thymoma and thymic carcinoma
Participants will
receive a fixed dose of 10 mgkg given intravenously once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity
have regular blood tests scans and examinations to monitor their health
have blood and a biopsy of their tumor for research purposes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None