Advanced Solid TumorsPhase 1NCT07615894
WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)
A Phase 1 study testing WSK-IM02 in people with Advanced Solid Tumors and Malignant Pleural Effusions, run by WestVac Biopharma Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors, Malignant Pleural Effusions, Malignant Ascites
- What is being tested?
- WSK-IM02
- 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
- 1 Jun 2026to 30 Jun 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ting Liu, 19182843926, 1924658083@qq.com
About this study
Official title: 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
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.
- Being tested
- WSK-IM02
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WSK-IM02Biological
WSK-IM02 is an injectable pMVA-1 lipid complex
| Study group | Role | What they receive |
|---|---|---|
| intrapleural/intraperitoneal infusion of WSK-IM02 | Experimental | Not described Receives: Biological: WSK-IM02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events (AE)
Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.
Measured: up to 28 days
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: up to 12 months
Progression-free survival (PFS)
PFS is defined as the time from the administration of the first dose to first disease.
Measured: up to 12 months
Overall survival (OS)
OS is defined as the time from the administration of the first dose to death.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615894
- Sponsor's protocol ID
- WSK IM02-2
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07615894
- Acronym / sponsor ID
- WSK IM02-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intrapleural/intraperitoneal infusion of WSK-IM02 | Experimental | Biological: WSK-IM02 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WSK-IM02WSK-IM02 is an injectable pMVA-1 lipid complex | Biological | intrapleural/intraperitoneal infusion of WSK-IM02 |
Primary outcome
adverse events (AE)
Time frame: up to 28 days
Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.
3 secondary outcomes
Objective response rate (ORR)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WSK-IM02 in people with Advanced Solid Tumors and Malignant Pleural Effusions, run by WestVac Biopharma Co., Ltd. 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 9 inclusion and 19 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 29 May 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (AE) (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.