New injection targets cancer fluid in lungs and belly
NCT ID NCT07615894
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests a new drug called WSK-IM02 in 9 people with advanced solid tumors that have spread to cause fluid buildup around the lungs or in the belly. The drug is given directly into the chest or abdomen to see if it is safe and can shrink tumors or reduce fluid. Participants must have failed standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WSK-IM02 (an injectable lipid complex)
- What this could lead to
- If it works, this could point toward a new treatment to control fluid buildup and tumors in advanced cancer patients.
- What could go wrong
- This is a very early, small phase 1 trial with only 9 participants, so it may not show clear benefit or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years and ≤75 years. 2. Voluntarily sign informed consent form. 3. Patients with histologically or cytologically confirmed advanced solid tumors. 4. 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. 5. Have received standard systemic therapy and developed clinical symptoms of serous cavity metastasis. 6. 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. 7. Life expectancy ≥3 months. 8. Adequate major organ function. 9. 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. Exclusion Criteria: 1. Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug. 2. 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. 3. 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). 4. 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. 5. Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment. 6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment. 7. Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection. 8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy. 9. Pregnant or breastfeeding women. 10. Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment. 11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled/intra-articular steroids are permitted). 12. 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. 13. Have poorly controlled or severe cardiovascular disease. 14. Have poorly controlled metabolic disease or complete/severe gastrointestinal obstruction requiring intervention. 15. Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin. 16. Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency. 17. Active local infection at the administration site. 18. Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis/abdominocentesis or catheter placement. 19. Have any other concurrent, serious, and/or uncontrolled medical condition.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors