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

NCT07615894 | Not Yet Recruiting Phase 1

• 1 other identifier: WSK IM02-2
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors; Malignant Pleural Effusions; Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• adverse events (AE)

  Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.

  up to 28 days

Secondary Outcomes (3)

• Objective response rate (ORR)

  up to 12 months

• Progression-free survival (PFS)

  up to 12 months

• Overall survival (OS)

  up to 12 months

Study Arms (1)

intrapleural/intraperitoneal infusion of WSK-IM02

EXPERIMENTAL

Biological: WSK-IM02

Interventions

WSK-IM02 BIOLOGICAL

WSK-IM02 is an injectable pMVA-1 lipid complex

intrapleural/intraperitoneal infusion of WSK-IM02

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)