WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)

Официальное название

A Single-Arm, Open-Label, Prospective Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of WSK-IM02 in Patients With Advanced Solid Tumors Complicated by Malignant Pleural or Peritoneal Effusions

Обзор

This is a prospective, single-center, interventional, phase I, dose-escalation, single-arm study designed to evaluate the safety, tolerability, and preliminary efficacy of intrapleural/intraperitoneal infusion of WSK-IM02 in patients with advanced solid tumors complicated by malignant pleural or peritoneal effusions who have failed standard of care.

Вмешательства

• Биопрепарат WSK-IM02
  WSK-IM02 is an injectable pMVA-1 lipid complex

Первичные конечные точки

• adverse events (AE) [Срок оценки: up to 28 days]

Вторичные конечные точки (3)

• Objective response rate (ORR) [Срок оценки: up to 12 months]
• Progression-free survival (PFS) [Срок оценки: up to 12 months]
• Overall survival (OS) [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

• Age ≥18 years and ≤75 years.
• Voluntarily sign informed consent form.
• Patients with histologically or cytologically confirmed advanced solid tumors.
• Histologically or cytologically confirmed malignant pleural/peritoneal effusion requiring drainage; or, in the absence of histologic/cytologic evidence, pleural effusion with clear imaging evidence of malignant pleural/peritoneal lesions on chest/abdominal CT and diagnosed as malignant pleural/peritoneal tumor in clinical practice.
• Have received standard systemic therapy and developed clinical symptoms of serous cavity metastasis.
• ECOG performance status: 0-2 points. Patients with ECOG 3 may be included if, in the investigator's judgment, removal of the effusion could improve the score to 2 or above.
• Life expectancy ≥3 months.
• Adequate major organ function.
• Able to tolerate thoracentesis/abdominocentesis and catheter placement, or already have a functional thoracic/abdominal drainage catheter in place, and agree to receive study drug treatment via this route.

Критерии исключения

• Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.
• Received local intracavitary therapy for pleural/peritoneal effusion (excluding diagnostic or symptom-relieving puncture/drainage) within 2 weeks prior to the first dose of study drug.
• Received extra-thoracic/extra-abdominal radiotherapy within 2 weeks prior to the first dose of study drug, or received radical radiotherapy to pleural/peritoneal or pulmonary/abdominal lesions within 8 weeks prior to enrollment (palliative radiotherapy to chest/abdomen is permitted).
• Underwent major thoracic or abdominal surgery within 4 weeks prior to the first dose of study drug and not fully recovered, or planned to undergo elective major surgery during the study period.
• Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment.
• Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment.
• Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection.
• Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy.
• Pregnant or breastfeeding women.
• Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment.
• Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled/intra-articular steroids are permitted).
• Require systemic corticosteroids or other immunosuppressants within 2 weeks prior to the first dose of study drug, and expected to require long-term use during the study.
• Have poorly controlled or severe cardiovascular disease.
• Have poorly controlled metabolic disease or complete/severe gastrointestinal obstruction requiring intervention.
• Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin.
• Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency.
• Active local infection at the administration site.
• Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis/abdominocentesis or catheter placement.
• Have any other concurrent, serious, and/or uncontrolled medical condition.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07615894 · WSK IM02-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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