[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-pleural-effusions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-pleural-effusions":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100640827","phase-1-wsk-im02-in-advanced-solid-tumors-with-malignant-effusions-phase-i-100640827",false,"NCT07615894","WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I)","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","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years.\n2. Voluntarily sign informed consent form.\n3. Patients with histologically or cytologically confirmed advanced solid tumors.\n4. Histologically or cytologically confirmed malignant pleural\u002Fperitoneal effusion requiring drainage; or, in the absence of histologic\u002Fcytologic evidence, pleural effusion with clear imaging evidence of malignant pleural\u002Fperitoneal lesions on chest\u002Fabdominal CT and diagnosed as malignant pleural\u002Fperitoneal tumor in clinical practice.\n5. Have received standard systemic therapy and developed clinical symptoms of serous cavity metastasis.\n6. 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.\n7. Life expectancy ≥3 months.\n8. Adequate major organ function.\n9. Able to tolerate thoracentesis\u002Fabdominocentesis and catheter placement, or already have a functional thoracic\u002Fabdominal drainage catheter in place, and agree to receive study drug treatment via this route.\n\nExclusion Criteria:\n\n1. Participation in any other interventional clinical trial within 4 weeks prior to the first dose of study drug.\n2. Received local intracavitary therapy for pleural\u002Fperitoneal effusion (excluding diagnostic or symptom-relieving puncture\u002Fdrainage) within 2 weeks prior to the first dose of study drug.\n3. Received extra-thoracic\u002Fextra-abdominal radiotherapy within 2 weeks prior to the first dose of study drug, or received radical radiotherapy to pleural\u002Fperitoneal or pulmonary\u002Fabdominal lesions within 8 weeks prior to enrollment (palliative radiotherapy to chest\u002Fabdomen is permitted).\n4. 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.\n5. Any toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 at the start of study treatment.\n6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that, in the investigator's judgment, make the patient unsuitable for enrollment.\n7. Known human immunodeficiency virus (HIV) infection, active hepatitis B, active hepatitis C, or active syphilis infection.\n8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungal therapy.\n9. Pregnant or breastfeeding women.\n10. Definite history of severe mental or cognitive disorders that, in the investigator's opinion, may affect study compliance or safety assessment.\n11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (topical glucocorticoids or inhaled\u002Fintra-articular steroids are permitted).\n12. 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.\n13. Have poorly controlled or severe cardiovascular disease.\n14. Have poorly controlled metabolic disease or complete\u002Fsevere gastrointestinal obstruction requiring intervention.\n15. Hypersensitivity to the investigational drug, any of its excipients, liposomal formulations, or kanamycin.\n16. Have had a major thromboembolic event within 6 months prior to the first dose, or have a clear bleeding tendency.\n17. Active local infection at the administration site.\n18. Uncorrectable coagulation dysfunction that would pose a high risk for thoracentesis\u002Fabdominocentesis or catheter placement.\n19. Have any other concurrent, serious, and\u002For uncontrolled medical condition.","ALL","18 Years","75 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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\u002Fintraperitoneal infusion of WSK-IM02 in patients with advanced solid tumors complicated by malignant pleural or peritoneal effusions who have failed standard of care.",[27,28,29],"Advanced Solid Tumors","Malignant Pleural Effusions","Malignant Ascites","NOT_YET_RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":21},"2026-06-01",{"date":38,"type":21},"2029-06-30",{"name":40,"class":41},"WestVac Biopharma Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100481002","phase-1-a-phase-ibii-clinical-trial-of-m701-in-the-treatment-of-malignant-pleural-effusions-caused-by-nsclc-100481002","NCT05543330","A Phase Ib\u002FII Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC","A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK\u002FPD and Preliminary Efficacy of M701, a Recombinant Epcam and CD3 Bispecific Antibody , in Patients With Malignant Pleural Effusions Caused by NSCLC","Inclusion Criteria:\n\n1. Males or females, aged \\> 18 years.\n2. Histologically- or cytologically-confirmed non-small cell lung cancer that has progressed after first line systemic therapy.\n3. Malignant pleural effusion diagnosed histologically or cytologically, with moderate or above moderate pleural fluid (sitting pleural fluid depth ≥ 4 cm via ultrasound, expected pleural fluid volume ≥ 500 mL) . Require clinical intervention and not treated yet.\n4. Patients who have an washout period of ≥ 4 weeks or 5 half-life of the drug (including radiotherapy, chemotherapy, immunotherapy, biologic, targeted, hormonal therapy, and 14 days for local radiotherapy) between the last systemic therapy and the first dose; however, no washout period is required if the subject has new pleural fluid or poor control of current pleural fluid after at least 2 cycle systemic therapy.\n5. Patients who had recovered to grade 0-1 of any toxic reaction to prior antineoplastic therapy as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0, with the exception of alopecia, hyperpigmentation and ≤ grade 2 neuropathy, hormone replacement hypothyroidism or other adverse events confirmed to have turned chronic.\n6. Patients with physical status ECOG score (PS) of 0-2.\n7. Patients with life expectancy ≥ 12 weeks.\n8. Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL, platelet count ≥ 100 ×10\\^9\u002FL, hemoglobin ≥ 8.5 g\u002FdL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin (TBIL)≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN.\n9. Patients must understand and voluntarily sign the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with asymptomatic pleural fluid and not requiring clinical intervention, or bilateral malignant pleural fluid, or proposed perfusion of the chest cavity presenting with pleural fluid separation.\n2. Patients with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients previously treated for brain metastases may be enrolled if they have been asymptomatic for ≥ 4 weeks prior to the first dose and have imaging indicating stable disease and do not require corticosteroid or anticonvulsant therapy.\n3. Patients with a known history of severe allergy to M701 drug components or antibody-like macromolecular drugs.\n4. Patients with contraindications to thoracentesis.\n5. Patients who have undergone major surgical procedures within 4 weeks prior to the first dose.\n6. Patients with extensive liver metastases (\\>70%).\n7. Patients with uncontrollable active infection (NCI-CTCAE V5.0 ≥ grade 2).\n8. Patients required long-term hormonal or immunosuppressive therapy, e.g. active autoimmune disease, maintenance therapy after organ transplantation, except that the following are allowed to enter screening: type I diabetes mellitus, hypothyroidism that can be controlled by replacement therapy only, skin diseases that do not require systemic therapy (e.g. vitiligo, psoriasis or alopecia).\n9. Patients with severe respiratory disease which, in the judgment of the investigator, makes them unsuitable for entry; or combined interstitial pneumonia.\n10. Patients with history of severe cardiovascular disease, including previous coronary artery bypass grafting or coronary stenting, myocardial infarction within 6 months, congestive heart failure (New York Classification of Cardiac Function Class III-IV) or unstable angina, or uncontrolled hypertension.\n11. Patients with QTc interval \\> 480 ms,family or personal history of long or short QT syndrome, clinically significant history of ventricular arrhythmias or implantation of a defibrillation device for ventricular arrhythmias.\n12. Patients with a history of (non-study tumour) malignancy (except squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other, non-invasive lesions that the investigator and sponsor agree have been cured and have a minimal risk of recurrence within 3 years) within 3 years prior to the date of first study drug administration.\n13. Patients who have active hepatitis B (HBV-DNA quantification ≥ 1 x 10\\^4 copies\u002FmL or 2000 IU\u002FmL), active hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection of the assay), active syphilis with positive HIV antibodies.\n14. Pregnant or breastfeeding woman,Plan to conceive within six months;\n15. Patients with a confirmed history of neurological or mental disorders, including epilepsy and dementia.\n16. Those that are deemed ineligible for this clinical trial by investigator.",{"count":51,"type":21},96,[24,53],"PHASE2","This is a phase 1\u002Fphase 2, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of M701 in patients with treatment of malignant pleural effusions caused by NSCLC.",[28,56],"NSCLC Stage IV",[28,58],"NSCLC","RECRUITING","2026-05-11",{"date":62,"type":34},"2026-05-14",{"date":64,"type":34},"2022-09-30",{"date":66,"type":21},"2026-12-15",{"name":68,"class":41},"Wuhan YZY Biopharma Co., Ltd."]