Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432296
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-18
Brief Title:
Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody
Sponsor:
Wuhan YZY Biopharma Co Ltd
Organization:
Wuhan YZY Biopharma Co Ltd
Study Overview
Official Title:
A Randomized Controlled Multi-Center Phase III Clinical Study to Evaluate the Efficacy and Safety of M701 for Intraperitoneal Injection in Patients With Malignant Ascites Caused by Advanced Epithelial Solid Tumors
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:
A Randomized Controlled Multi-Center Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody M701 for Intraperitoneal Injection to Paracentesis alone in Patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors
Detailed Description:
The phase III study is a controlled open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors who are also receiving systemic therapy
A total of 270 patients with malignant ascites caused by Malignant Ascites Caused by Advanced Epithelial Solid Tumors will be randomly assigned to two treatment arms in a 21 ratio These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy
Both treatment arms will receive the systemic therapy as per the investigators instructions The test arm will receive paracentesis and intra-peritoneal infusion of M701 while the control arm will receive paracentesis alone
The primary endpoint of the study is the puncture-free survival which evaluates the efficacy of M701 in controlling malignant ascites Secondary endpoints include the overall survival OSTime to next puncture TTNP Patient-reported outcome PRO score 6-month survival rate1-month and 2-month puncture-free survival rate safety profilesand Anti-m701 antibody ADA and Neutralizing antibody NAb
A total of 270 patients with malignant ascites caused by Malignant Ascites Caused by Advanced Epithelial Solid Tumors will be randomly assigned to two treatment arms in a 21 ratio These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy
Both treatment arms will receive the systemic therapy as per the investigators instructions The test arm will receive paracentesis and intra-peritoneal infusion of M701 while the control arm will receive paracentesis alone
The primary endpoint of the study is the puncture-free survival which evaluates the efficacy of M701 in controlling malignant ascites Secondary endpoints include the overall survival OSTime to next puncture TTNP Patient-reported outcome PRO score 6-month survival rate1-month and 2-month puncture-free survival rate safety profilesand Anti-m701 antibody ADA and Neutralizing antibody NAb
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None