Spots Global Cancer Trial Database for A Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites

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Trial Identification

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

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

Study ID: NCT06415500

Conditions

Gynecologic Cancer

Interventions

NK042

Study Description

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 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.