AzTrials
AzTrials

Gynecologic CancerPhase 1NCT06415500

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

A Phase 1 study testing NK042 in people with Gynecologic Cancer, run by Anhui Provincial Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gynecologic Cancer
What is being tested?
NK042
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
6 May 2024to 6 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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);
  • Fertility capable subjects (male and female) must agree to use reliable;contraceptive methods (hormone or barrier methods or abstinence) during the trial and at least 1 year after the last dose; Female subjects of reproductive age must have a negative blood or urine pregnancy test within 14 days before enrollment;
  • For previous anti-malignant ascites therapy (except systemic chemotherapy to control the primary tumor), the washout period is set to 2 weeks or 5 half-lives after the end of the last dose, whichever is shorter;
  • The subjects were able to communicate well with the researchers, and understand and comply with the requirements of this trial.

Who cannot join

  • 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);
Show all 18Show fewer
  • 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%;
  • Subjects with chronic or relapsed severe autoimmune or immune-mediated disease requiring high-dose steroid or other immunosuppressive therapy;
  • The presence of central nervous system (CNS) metastases is known;
  • Subjects with active systemic infections requiring treatment, including, but not limited to, subjects with active tuberculosis, subjects with Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) positivity and peripheral blood HBV DNA titers greater than the upper limit of detection, subjects who are RNA positive for Hepatitis C (HCV), subjects who are seropositive for Human Immunodeficiency Virus (HIV), subjects who are seropositive for Helicobacter syphilis, etc.; and Subjects who are seropositive for Hepatitis C (HCV);
  • Subjects who have previously undergone liver transplantation, organ allograft transplantation, or renal replacement therapy;
  • Active lung disease, including but not limited to interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc;
  • Meet any of the following criteria, 1) history of abuse of psychotropic substances and unable to abstain or with mental disorders, 2) have a serious concomitant disease that endangers the safety of the patient or affects the completion of the trial judged by the researcher;
  • Women during pregnancy or lactation;
  • Hypersensitivity to albumin, DMSO;
  • Co-existing HBV and HCV and two or more viral infections;
  • The researcher judge the patient with factors that may affect the results of the study or interfere the participation in the entire study process, including but not limited to previous or existing physical conditions, treatment or laboratory abnormalities, etc; Or putting the patient in a high-risk situation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Zhou, MD contact

+8613865901025

caddiezy@ustc.edu.cn

China1 site

  • Anhui Provincal Hospital

    Hefei, Anhui, 230001

    Ying Zhou, MD, +8613865901025, caddiezy@ustc.edu.cn

Other trials in China

About this study

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

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

Read the 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.

Being tested
NK042
Keywords
malignant ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NK042Drug

    Also called NKR-NK

    NK042 intraperitoneal infusion on Days 0,7 and 14.

Study groups in NCT06415500
Study groupRoleWhat they receive
NK042ExperimentalNot described
Receives: Drug: NK042

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The occurrence of DLTs will be observed from the first intraperitoneal infusion of NK042 to 28 days after infusion.

    Measured: 28 Days

Secondary outcomes (5)

  1. ascites volume

    Five-point method to measure ascites volume(base on CT).

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).

  2. Time to next therapeutic puncture，TTpu

    The time to the next puncture/drainage

    Measured: From the time of first dosing (Day 1) to the next puncture/drainage (up to 6 months)

  3. Puncture-free survival, PuFS

    The time to the next puncture/drainage or death

    Measured: From the time of of first dosing (Day 1) to the next puncture/drainage or death (up to 6 months)

  4. Progression-free Survival, PFS

    The time to disease progression assessed by the imaging evaluation or toxicity or death

    Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance or death (up to 6 months).

  5. Overall survival, OS

    The time to death

    Measured: From the time of first dosing (Day 1) until death (up to 6 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start6 May 2024 (estimated)
  3. Primary completion6 Dec 2025 (estimated)
  4. Study completion6 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06415500
Sponsor's protocol ID
NK042-IIT-MA
Status last verified
May 2024
First submitted
7 May 2024
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NK042 in people with Gynecologic Cancer, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Zhou, MD (+8613865901025, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) and Dose-limiting Toxicity (DLT) (time frame: 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in