[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urological-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urological-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100650231","phase-1-a-study-of-si-b036-in-patients-with-locally-advanced-or-metastatic-urological-tumors-and-other-solid-tumors-100650231",false,"NCT07744243","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥ 18 years and ≤ 75 years;\n4. Expected survival time ≥ 3 months;\n5. Locally advanced or metastatic urological tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens collected within 2 years from the primary or metastatic lesion, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;\n11. Organ function levels must meet the specified requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤ 1.5, and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN);\n13. Urine protein ≤ 1+ or ≤ 1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment, with a negative result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 6 months after the completion of treatment;\n15. The trial participant must be willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior history of ≥ Grade 3 toxicity related to anti-angiogenic therapy when receiving such treatment previously;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetes mellitus with poor glycemic control;\n11. History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Active central nervous system (CNS) metastases;\n14. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of SI-B036;\n15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug;\n18. Presence of pleural, abdominal, or pelvic effusion, or pericardial effusion requiring drainage and\u002For associated with symptoms within 4 weeks prior to the first dose of the study drug;\n19. Imaging findings indicating that the tumor has invaded or encased the great thoracic vessels, pericardium, or heart;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Other conditions that, in the investigator's opinion, make the subject unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is an open-label, multicenter, dose-escalation and dose-expansion, non-randomized phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic urological tumors and other solid tumors.",[27,28],"Urological Cancer","Solid Cancer","NOT_YET_RECRUITING","2026-08-04",{"date":32,"type":33},"2026-08-06","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY"]