NCT06415500

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	NK042	NK042 intraperitoneal infusion on Days 0,7 and 14.

Timeline

• Start date: 2024-05-06
• Primary completion: 2025-12-06
• Completion: 2026-12-06
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: China