Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415500
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
A Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
A Single Center Open Single Arm Clinical Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites
Status:
NOT_YET_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 purpose of this study is to assess the safety and efficacy of NK042 for treatment of malignant ascites
Detailed Description:
This is a phase 1 open-label Single Armdose escalation study to evaluate the safety tolerability PK PD and preliminary efficacy of NK042 in patients with treatment of malignant ascites caused by Gynecologic CancerAbout 3-9 subjects are planned to be enrolled Subjects will receive intraperitoneal infusion of NK042 once a week D0D7D14for 2 cycles with 3 times during each cycle and a total of 6 infusions The occurrence of DLTs will be observed from the first intraperitoneal infusion of NK042 to 28 days after infusion
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