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A Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites

Gynecologic Cancer Clinical Trial

Official title:
A Single Center, Open, Single Arm Clinical Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of NK042 for treatment of malignant ascites.

Clinical Trial Description

This is a phase 1 ,open-label , Single Arm,dose escalation study to evaluate the safety, tolerability, PK, PD and preliminary efficacy of NK042 in patients with treatment of malignant ascites caused by Gynecologic Cancer.About 3-9 subjects are planned to be enrolled, Subjects will receive intraperitoneal infusion of NK042 once a week (D0、D7、D14)for 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06415500
Study type Interventional
Source Anhui Provincial Hospital
Contact Ying Zhou, MD
Phone +8613865901025
Email caddiezy@ustc.edu.cn
Status Not yet recruiting
Phase Phase 1
Start date May 6, 2024
Completion date December 6, 2026
View Details
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