[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575197":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":51,"collaborators":29,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":29,"overallStatus":43,"whyStopped":29,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"HLX43 2.0mg\u002Fkg","EXPERIMENTAL","every 3 weeks (Q3W)",[13],"Drug: HLX43",{"label":15,"type":10,"description":11,"interventionNames":16},"HLX43 2.5mg\u002Fkg",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"HLX43 3.0mg\u002Fkg",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"HLX43 3.0mg\u002Fkg loading dose",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","HLX43","HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.",[9,15,18,21],null,[31],{"name":32,"affiliation":33,"role":34},"Jinming Yu, Dr.","Shandong Cancer Hospital and Institute","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","0531-67626971","sdyujinming@126.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":29,"country":46,"countryCode":47,"cosmosGeoPoint":29,"geoPoint":29,"contacts":48},"Shandong Cancer Hospital","RECRUITING","Ji'nan","Shandong","China","CN",[49,50],{"name":32,"role":37,"phone":42,"phoneExt":29,"email":39},{"name":32,"role":34,"phone":29,"phoneExt":29,"email":29},{"type":52,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100575197","phase-2-a-phase-ii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx43-anti-pd-l1-adc-in-patients-with-advanced-gynecological-malignant-tumors-100575197",false,"NCT06769152","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant Tumors","A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Recurrent\u002FMetastatic Gynecological Malignant Tumors Failed or Intolerance to Standard First-Line Therapy","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research; To fully understand and understand this study and to sign the Informed Consent Form (ICF); Willing to follow and able to complete all test procedures;\n2. The age of signing ICF is ≥ 18 years old and ≤ 75 years old;\n3. Cohort 1: Metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology confirmed by histopathology or cytology.\n\n   Cohort 2: Histologically confirmed high-grade serous ovarian, fallopian tube, or primary peritoneal cancer.\n4. Cohort 1: Previous failure or progression of standard systemic therapy for cervical cancer (For patients with PD-L1 expression positive \\[CPS≥1\\], the standard therapy is defined as platinum-based chemotherapy in combination with immune checkpoint inhibitor (ICI) therapy; for patients with PD-L1 expression negative \\[CPS\\\u003C1\\], the standard therapy is defined as platinum-based chemotherapy), or intolerability toxicity (CTCAE≥3 adverse events), or contraindications to standard therapy.\n\n   Cohort 2: Ovarian cancer patients with platinum-resistant disease: If the patient has previously received only first-line platinum-based chemotherapy, platinum resistance is defined as having received at least 4 cycles of platinum-based chemotherapy, with the tumor showing a response to platinum-based chemotherapy (best tumor assessment being complete remission\u002Fpartial remission), and the time from the last platinum-based chemotherapy to tumor progression being \\>3 months and ≤6 months. If the patient has previously received multiple lines of platinum-based chemotherapy, platinum resistance is defined as disease progression occurring during the last line of platinum-based chemotherapy treatment or within 6 months after the last platinum-based chemotherapy.\n5. Within 4 weeks prior to the first administration of the medication, at least one measurable target lesion must be evaluated according to the RECIST v1.1 criteria;\n6. Tumor tissue should be provided as much as possible for an evaluable PD-L1 expression result at Screening period；\n7. Before the initial administration of the study drug, there should be at least a 3-week interval or 5 times the half-life of the last cytotoxic chemotherapy, immunotherapy, or biological therapy, whichever is shorter. There should be at least a 2-week interval from the previous small molecule targeted therapy, at least a 1-week interval from traditional Chinese medicine treatment with antitumor indications or minor surgery. Additionally, treatment-related adverse events (AEs) should have recovered to NCI-CTCAE grade ≤ 1 (except for grade 2 peripheral neurotoxicity and alopecia)；\n8. The ECOG physical performance score of 0-1 in the week prior to randomization；\n9. Expected survival ≥ 3 months；\n10. Laboratory tests within the previous week confirm adequate organ function (within 14 days prior to the first dose of medication, without receiving interventions such as blood transfusions or granulocyte colony-stimulating factor)；\n11. Female subjects of childbearing potential must agree to use at least one highly effective method of contraception during the trial and for at least 6 months after the last dose of the study drug. Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n\nExclusion Criteria:\n\n1. History of any second malignant tumor within the first 2 years prior to randomization;\n2. Subjects who are preparing for or have previously received an organ or bone marrow transplant;\n3. Symptomatic, untreated, or progressively worsening central nervous system (CNS) or leptomeninges metastases;\n4. After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently;\n5. Present with grade ≥1 radiation pneumonia as defined by RTOG\u002FEORTC; A history of interstitial lung disease (ILD) or imaging findings during screening that suggest such disease is suspected; Or there are lung diseases leading to clinical severe respiratory impairment;\n6. Subjects exhibit poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure, or left ventricular ejection fraction (LVEF) \\\u003C 50%; (2) unstable angina; (3) myocardial infarction or cerebrovascular accident within the last 6 months (excluding lacunar infarction, minor ischemic stroke, or transient ischemic attack); (4) uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females) (QTc interval calculated by Fridericia's formula); (5) poorly controlled hypertension (systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg despite active treatment);\n7. Previous occurrence of adverse events leading to permanent discontinuation of immunotherapy; or A history of ≥ Grade 2 immune-related pneumonia or myocarditis;\n8. Active or suspected autoimmune disease. Patients with autoimmune-related hypothyroidism who are undergoing thyroid hormone replacement therapy are permitted to participate in the study; patients with controlled Type 1 diabetes mellitus receiving insulin therapy are also allowed to participate in the study;\n9. Received systemic corticosteroids (prednisone \\>10 mg\u002Fday or an equivalent dose of similar drugs) or other immunosuppressive treatments within 14 days prior to the first dose; with the following exceptions: use of topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment during situations such as the use of contrast agents;\n10. Within the 2 weeks prior to randomization, there is the presence of an active systemic infectious disease requiring intravenous antibiotic treatment;\n11. Live vaccinations or attenuated live vaccinations should not be administered within 4 weeks prior to the initial dosing. Administration of inactivated viral vaccines for seasonal influenza is permitted;\n12. Used strong inhibitors or strong inducers of CYP2D6 or CYP3A within 2 weeks prior to randomization;\n13. Known history of severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, or allergy to components of the trial drug formulation; Previously received ADC drugs with topoisomerase I inhibitors as toxins.\n14. Active tuberculosis;\n15. Human immunodeficiency virus (HIV) infection;\n16. Active Hepatitis B or Hepatitis C virus (HBV or HCV) infection or HBV\u002FHCV co-infection;\n17. Pregnant or lactating women;\n18. The researcher deems that the subject has any other factors that make them unsuitable for participation in this trial.","FEMALE","18 Years","75 Years",{"count":64,"type":65},190,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent\u002Fmetastatic cervical cancer or ovarian cancer failed or intolerance to standard first-line therapy.",[71,72],"Cervical Cancer","Ovarian Cancer","2026-04-17",{"date":75,"type":76},"2026-04-22","ACTUAL",{"date":78,"type":76},"2025-02-20",{"date":80,"type":65},"2027-06-05",{"name":5,"class":6},1]