Not Yet RecruitingPhase 1

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

China9 participantsStarted 2024-05-06

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients have the ability to know and sign informed consent;
✓. Age 18-70 years old; any sex;
✓. Histologically or pathologically confirmed Gynecologic Cancer,including but are not limited to patients with malignant ascites caused by advanced malignant tumors such as ovarian cancer and endometrial cancer;
✓. The volume of ascites ≥1L based on CT or more than the same amount of abdominal fluid (definition: abdominal fluid ≥4.5cm detected by B ultrasound in lying position, accompanied by clinical symptoms such as abdominal distension and discomfort);
✓. Ascites should be treated by puncture;
✓. Expected survival time ≥ 12 weeks;
✓. the Eastern Cooperative Oncology Group (ECOG) scored 0-2 points;
✓. Appropriate organ and bone marrow function,Laboratory test results must meet the following criteria(unless otherwise specified, the test results of the research center shall prevail)： (1)blood routine examination: White blood cell count \> 3×10\^9/L; Absolute neutrophil Count (ANC)≥1.5×10\^9/L; Haemoglobin \> 90 g/L; lymphocyte count ≥ 0.7×10\^9/L; Platelet count ≥ 75×10\^9/L. (2)renal function: Serum creatinine and/or urea \< 1.5×ULN; serum total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal value (ULN)(bilirubin ≤ 3×ULN for patients with Gilbert's syndrome; (3)liver function: ALT and AST ≤ 2.5 × ULN(≤ 5×ULN for patients with complication of liver metastases);

Exclusion criteria

✕. Currently, or within 30 days prior to enrollment, participating in a clinical trial of another drug or biologic therapy, or having received comparable cellular therapy;
✕. Patients undergoing treatment for intraperitoneal malignant ascites, including therapeutic paracentesis;
✕. Systemic or other treatments that have a significant impact on the evaluation of efficacy are determined according to the study;
✕. Patients with extensive liver metastases Patients with extensive liver metastases (tumor volume occupying approximately \>70% of total liver volume);
✕. Occurrence of complete intestinal obstruction within 30 days before the first dose, or diagnosis of incomplete intestinal obstruction deemed unsuitable for participation in the trial based on symptoms and signs as determined by the investigator;
✕. Laboratory results indicating bacterial peritonitis (neutrophil count \> 250 / µl ascites);
✕. Serum albumin ≤ 30 g/L;
✕. Meet any of the following criteria related to cardiac function: 1) Various clinical significant arrhythmia or conduction abnormalities that require clinical intervention; 2) Congenital QT interval prolongation syndrome or men with QTc\>450 msec and women with QTc\>470 msec (QTc is calculated using Fridericia's correction formula), or taking drugs that may cause QT interval prolongation or torsade de pointe arrhythmia; 3) Various clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass surgery or peripheral artery bypass grafting surgery, and cerebrovascular events (referring to thromboembolic or hemorrhagic cerebrovascular events, excluding cerebrovascular events caused by anemia caused by underlying disease ) within the first 6 months of enrollment, congestive heart failure with a New York Heart Association (NYHA, Attachment 8) rating of 3 or higher, or a left ventricular ejection fraction (LVEF) of\<50%;

What they're measuring

Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT)

Timeframe: 28 Days

Trial details

NCT IDNCT06415500

SponsorAnhui Provincial Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-06

Contact for this trial

Ying Zhou, MD

+8613865901025 caddiezy@ustc.edu.cn

View on ClinicalTrials.gov More Gynecologic Cancer trials