Not Yet RecruitingPhase 1/2

SK-NK Injection in Patients With Advanced Solid Tumors Accompanied by Malignant Ascites

10 participantsStarted 2025-05-30

Plain-language summary

This study is divided into two phases. Patients with recurrent or metastatic solid tumors accompanied by malignant ascites who have failed previous standard treatments are enrolled. The first phase is a single-arm, open-dose exploratory Phase I clinical study. In this phase, two dose groups are preset, namely 20×108 cells and 30×108 cells. Subjects who meet the inclusion criteria will receive intravenous infusion of SK-NK injection. Once a week for 6 consecutive infusions. After completing 6 consecutive infusions of SK-NK injection, the researchers evaluated that the patient benefited and could continue to receive 6 consecutive infusions of SK-NK injection. After completing 12 infusions, whether to continue the treatment subsequently could be determined based on the patient's condition. The second stage will be based on the results of the first stage to further verify the clinical efficacy, safety, tolerability and pharmacokinetic characteristics of RP2D, etc.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Aged 18 to 75 years.
✓. Malignant solid tumors confirmed by histology or pathology, including: advanced gastric cancer, colorectal cancer, esophageal squamous cell carcinoma, gynecological malignancies, etc. that have failed at least two lines of treatment.
✓. Pathological diagnosis or clinical diagnosis combined with malignant ascites, and ascites drainage is not required within one week before the administration of the study.
✓. At least one measurable tumor lesion based on RECIST V1.1 criteria.
✓. ECOG PS ≤1.
✓. Expected survival ≥12 weeks.
✓. Adequate organ function.
✓. Non-reproductive female patients, or reproductive female patients whose pregnancy test results are negative and commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration, or male patients commit to taking adequate and effective contraceptive measures or abstinence from the screening period until 3 months after the last administration.

Exclusion criteria

What they're measuring

SK-NK injection safety and tolerance

Timeframe: up to 12 months

ORR

Timeframe: up to 12 months

Trial details

NCT IDNCT06991478

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

Contact for this trial

TING DENG

15802243063 18526812877@163.com

View on ClinicalTrials.gov More Solid Tumor, Malignant Ascites trials