A Study on the Safety and Preliminary Efficacy of NK042 in the Treatment of Malignant Ascites
- Sponsor
- Anhui Provincial Hospital
- Study ID
- NCT06415500
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Gynecologic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- NK042 — DRUGNK042 intraperitoneal infusion on Days 0,7 and 14.
Study Details
The purpose of this study is to assess the safety and efficacy of NK042 for treatment of malignant ascites.
Key Dates
- First listed
- May 16, 2024
- Start date
- May 6, 2024
- Status verified
- May 2024
- Primary completion
- Dec 6, 2025
- Completion
- Dec 6, 2026
Study Design
- Enrollment
- 9 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NK042
Primary Outcome Measure
Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) [ Time Frame: 28 Days ]
Central Contacts
- Ying Zhou, MD+8613865901025
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