[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bio-Thera Solutions\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":153},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,66,89,110,130],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100632545","phase-3-efficacy-evaluation-study-of-bat5906-and-lucentis-in-patients-with-diabetic-macular-edema-100632545",false,"NCT07515079","Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema","A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n* All of the following criteria must be met for inclusion:\n\n  1. Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.\n  2. Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).\n  3. Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);\n  4. Central retinal thickness (CRT) of the study eye \\>300 μm (or \\>320 μm for Heidelberg OCT) as assessed by central image review during screening;\n  5. Best-corrected visual acuity (BCVA) of the study eye between 73 and 21 letters (using ETDRS chart, including boundary values; equivalent to Snellen visual acuity scores of 20\u002F40 to 20\u002F400);\n  6. Contralateral eye BCVA \\> 24 letters (using ETDRS chart, equivalent to Snellen acuity 20\u002F320); Note: If both eyes meet inclusion criteria, the eye with poorer BCVA is selected as the study eye, unless the investigator determines the other eye is more suitable.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n\n  1. Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of macular edema, including retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia (as indicated by marked disruption of the arcade pattern on fluorescein angiography), or histochemical sclerosing exudates. 2. Vitreomacular traction or epimacular membrane deemed by the investigator to significantly impair visual improvement;\n  2. Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g., retinal vascular occlusion, retinal detachment, optic nerve ischemia, vitreomacular traction, macular hole, pre-retinal fibrosis involving the macula, choroidal neovascularization, age-related macular degeneration);\n  3. Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule opacification resulting from YAG capsulotomy, provided a 1-month washout period is met);\n  4. The study eye has uncontrolled glaucoma (intraocular pressure \\>25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration surgery; or plans for antiglaucoma surgery during the study period;\n  5. The study eye has undergone vitreoretinal surgery or scleral buckling;\n  6. The study eye has undergone panretinal photocoagulation (PRP) or focal\u002Fgrid PRP in the macular area within the preceding 3 months, or there is a possibility of undergoing PRP during the study period;\n  7. Presence of neovascular glaucoma, iris neovascularization, or other clinically significant iris lesions deemed abnormal by the investigator in the study eye;\n  8. Active proliferative diabetic retinopathy (PDR) in the study eye, characterized by fibrovascular proliferation, vitreous hemorrhage, and retinal detachment;\n  9. The study eye has undergone intraocular surgery within the past 3 months, or is scheduled to undergo intraocular surgery during the study period;\n  10. The study eye has refractive media opacities (e.g., corneal scarring, undilatable pupils, cataracts, vitreous hemorrhage) that interfere with visual acuity assessment or fundus examination;\n  11. The study eye has received intravitreal injection of long-acting or sustained-release corticosteroids (e.g., dexamethasone intravitreal implant) or high-dose oral corticosteroids (\\>10 mg prednisolone or equivalent daily dose) within 6 months prior to baseline, except for patients using inhaled, intranasal, or low-dose topical corticosteroids applied to the skin; the study eye had received intravitreal injections of short- or medium-acting corticosteroids (e.g., triamcinolone) within 3 months prior to baseline; Periorbital corticosteroid injections administered to the study eye within 1 month prior to baseline; Fluocortolone intravitreal implants used in the study eye at any time prior to baseline; Systemic corticosteroid therapy received within 5 days prior to baseline;\n  12. The equivalent spherical refractive error of the study eye exceeds -6.0 diopters. For patients with a history of refractive or cataract surgery, the refractive error of the study eye should not exceed -6.0 diopters preoperatively. If preoperative refractive results are unavailable, the measured axial length must not exceed 26mm;\n  13. History of uveitis in either eye;\n  14. Active ocular inflammation or infection (bacterial, viral, parasitic, or fungal) in either eye;\n  15. Receipt of anti-VEGF therapy in the study eye or systemic administration within 90 days (inclusive) prior to randomization;\n\n      Exclusion Criteria for Abnormal Laboratory Findings:\n  16. Abnormal liver or renal function (defined in this trial as ALT and AST not exceeding 2.5 times the upper limit of normal for this center's laboratory; Crea and BUN not exceeding 2 times the upper limit of normal for this center's laboratory);\n  17. Coagulation abnormalities (prothrombin time \\> 3 seconds above the upper limit of normal, activated partial thromboplastin time \\> 10 seconds above the upper limit of normal);\n  18. Patients with any active infection: positive hepatitis B screening (defined as positive hepatitis B surface antigen and HBV-DNA \\> 1000 IU\u002FmL or the hospital's maximum cutoff value), Positive screening for hepatitis C (defined as positive HCV antibodies and positive HCV-RNA), positive human immunodeficiency virus (HIV) antibodies, positive screening for Treponema pallidum antibodies (Anti-TP) (positive specific antibody test, negative non-specific antibody test, except for those clinically assessed as non-active infection).\n\n      Other exclusion criteria:\n  19. Acute cardiovascular or cerebrovascular disease, related treatment, or other thromboembolic disorders within 6 months prior to first dosing;\n  20. Poorly controlled diabetes or glycated hemoglobin (HbA1c) \\>11%;\n  21. Uncontrolled hypertension (defined as blood pressure \\>160\u002F95 mmHg despite antihypertensive medication);\n  22. Undergone surgery within the past month with unhealed wounds, or as determined by the investigator;\n  23. Diagnosed systemic autoimmune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus) or any uncontrolled clinical condition (e.g., malignancy, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory disorders);\n  24. History of conditions contraindicated for the study drug, metabolic dysfunction, physical examination findings, or diseases\u002Fsymptoms reasonably suspected based on clinical laboratory results that are contraindications for the study drug, may affect study outcome assessment, or expose the subject to a higher risk of complications;\n  25. Known allergy or contraindication to the study drug or its components, fluorescein, povidone-iodine, or indocyanine green;\n  26. Participation in any drug clinical trial (excluding vitamins and minerals) within 90 days prior to the first study dose (calculated from the last dose of the investigational drug; if the investigational drug has a long half-life, the period shall be 5 half-lives if \\>3 months);\n  27. Pregnant, pregnant women, or lactating women (pregnancy defined in this trial as a positive blood\u002Furine pregnancy test); Male or female subjects of reproductive potential who refuse to use appropriate contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study period and for 3 months after the last visit. Women defined as reproductive potential include those who have not yet reached menopause, or who have reached menopause but have not maintained a continuous menopausal state for \\>12 months, and who have not undergone sterilization (ovariectomy and\u002For hysterectomy). The definition of fertility may be adjusted according to local standards in each region.\n\n      Note: Highly effective contraceptive methods include complete abstinence, intrauterine devices, dual barrier methods (e.g., condom + spermicide-containing diaphragm), contraceptive implants, hormonal contraceptives \\[oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices, or depot injections\\], or a partner who has undergone vasectomy with confirmed azoospermia.\n  28. Other conditions deemed by the investigator to warrant exclusion.","ALL","18 Years","80 Years",{"count":20,"type":21},406,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).",[27],"Diabetic Macular Edema (DME)","RECRUITING","2026-03-30",{"date":31,"type":32},"2026-04-07","ACTUAL",{"date":34,"type":32},"2024-10-09",{"date":36,"type":21},"2027-04-30",{"name":38,"class":39},"Bio-Thera Solutions","INDUSTRY",50,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100631363","phase-2-a-clinical-study-of-bat4406f-injection-in-patients-with-minimal-change-diseasefocal-segmental-glomerulosclerosis-100631363","NCT07499700","A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis","A Phase II\u002FIII Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis","Inclusion Criteria:\n\n1. Clinically diagnosed with NS, with a pathological diagnosis of Minimal change disease\u002FFocal segmental glomerulosclerosis confirmed by renal biopsy within 7 years (Minimal change disease) or 10 years (Focal segmental glomerulosclerosis) prior to screening, and who are responsive to corticosteroid therapy\n2. The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline\n\nExclusion Criteria:\n\n1. Secondary Nephrotic Syndrome\n2. Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome\n3. Receipt of any B-cell depletion or B-cell-modifying therapy within 6 months prior to baseline\n4. History of allergy to monoclonal antibodies; or a predisposition to allergies\n5. Received treatment with immunosuppressants within 60 days prior to baseline\n6. Received immunoglobulin within 90 days prior to baseline; or received immunomodulators such as thymosin within 4 weeks prior to baseline\n7. Participation in a clinical trial of another investigational drug within 90 days prior to baseline or within 5 half-lives of the drug (whichever is longer), or plans to participate in a clinical trial of another drug during the study period\n8. Marked abnormalities in liver or kidney function\n9. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis C virus (HCV) antibodies; or positive for Treponema pallidum antibodies; or history of Human Immunodeficiency Virus or positive for Human Immunodeficiency Virus antibodies","75 Years",{"count":50,"type":21},192,[52,24],"PHASE2","This is a phase II\u002FIII multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of BAT4406F injection in patients with Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis",[55,56],"Minimal Change Disease (MCD)","Focal Segmental Glomerulosclerosis (FSGS)","2026-03-29",{"date":59,"type":32},"2026-04-03",{"date":61,"type":32},"2025-10-26",{"date":63,"type":21},"2030-11-26",{"name":38,"class":39},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100486895","phase-1-evaluate-the-safety-tolerability-and-pharmacokinetic-characteristics-of-bat8008-for-injection-100486895","NCT05620017","Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection","A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\nAll of the following items could be meet to be enrolled the study\n\n1. Age ≥18 years old, both sexes;\n2. Voluntarily sign the informed consent;\n3. Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically confirmed, have failed or not been treated with standard therapy, have been intolerant to or have refused standard therapy.\n4. According to RECIST1.1, there is at least one measurable tumor lesion;\n5. The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1;\n6. Investigators assessed the expected survival of ≥12 weeks;\n7. Adequate organ and bone marrow reserve function\n8. Fertile female patients willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period. Male patients must consent to use an effective method of contraception during the study;\n9. Willing to provide previously archived or fresh tumor tissue samples\n10. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.\n\nExclusion Criteria:\n\nIf you meet any of the following items, you will not be allowed to enroll this study :\n\n1. Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of medical devices;\n2. Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first administration), targeted therapy\u002Fimmunotherapy (at least 4 weeks or at least 5 half-life, whichever is shorter), hormone therapy (except alternative therapy);\n3. Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor effect;\n4. Before the first administration of the study drug, AE (CTCAE5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment;\n5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to be performed during the study period;\n6. Patients who have received Trop2 targeted therapy previously;\n7. Those who have received the treatment containing exatecan or irinotecan and other topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥ grade 3 or treatment failure of topoisomerase I inhibitor;\n8. Have a history of allograft cell or solid organ transplantation;",{"count":74,"type":21},182,[76],"PHASE1","Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.",[79],"Advanced Solid Tumors","2026-02-04",{"date":82,"type":32},"2026-02-09",{"date":84,"type":32},"2022-11-30",{"date":86,"type":21},"2027-05-31",{"name":38,"class":39},2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":65},"100606846","phase-1-a-study-evaluating-bat3306-compared-with-keytruda-in-nsclc-cancer-participants-100606846","NCT07180862","A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants","A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);\n  2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;\n  3. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Presence of EGFR gene mutation;\n  2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;\n  3. Have previously received any of the following treatments:\n\n     Have received \\> 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.\n\n     Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.\n\n     Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.\n  4. Prior treatment with anti-PD-1, anti-PD-L1\u002F2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.\n  5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;",{"count":97,"type":21},140,[76],"Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment",[101],"Carcinoma, Non-Small-Cell Lung","2025-12-31",{"date":104,"type":32},"2026-01-06",{"date":106,"type":32},"2025-10-14",{"date":108,"type":21},"2027-11-30",{"name":38,"class":39},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":65},"100544995","phase-1-a-multicenter-open-clinical-study-of-safety-tolerability-pharmacokinetic-profile-and-initial-clinical-efficacy-of-bat-8010-for-injection-combined-with-bat-1006-in-the-treatment-of-locally-advanced-or-metastatic-tumors-100544995","NCT06376136","A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors","An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib\u002FIIa Clinical Study","Inclusion Criteria:\n\n1. age ≥18 years old, male and female, voluntarily sign informed consent;\n2. Estimated survival ≥3 months as assessed by the investigators;\n3. the Eastern UnitedStates Cancer Consortium (ECOG) physicalstatu sscore requirements of 0 to 1 points;\n4. Included in the crowd:\n\n   1. Dose escalation stage: Patients with HER-2 expression confirmed by histopathology and cytopathology (including IHC3+, IHC2+\u002FFISH+ and IHC2+\u002FFISH-) who have failed standard therapy or have no standard treatment options or are not suitable for standard therapy at this stage, The climbing stage includes but is not limited to breast cancer, stomach cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial carcinoma, etc.\n   2. Dose expansion phase: divided into 3 cohorts i. Cohort A: Patients with breast cancer with HER-2 expression (including IHC3+, IHC2+\u002FFISH+ and IHC2+\u002FFISH-) confirmed by histopathology and cytopathology after failure of standard treatment or no standard treatment regimen or unsuitable for standard treatment at this stage; ii. Cohort B: Patients with histopathologically confirmed and inoperable locally advanced or metastatic urothelial carcinoma, including urinary bladder, pelvis, ureter, and urethral origin with HER-2 expression (including IHC3+, IHC2+\u002FFISH+, and IHC2+\u002FFISH-); iii. Cohort C: patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) with disease progression after standard therapy, or histologically or cytologically proven metastatic or unresectable locally advanced or metastatic HER-2 expression (including IHC3+, IHC2+\u002FFISH+, and IHC2+\u002FFISH-) who are intolerant to standard therapy;\n5. the dose escalation phase must have an evaluable tumor lesion, and the dose expansion phase must have at least one measurable tumor lesion (according to RECIST 1.1 criteria);\n6. Pregnant women must have a negative pregnancy test during the screening period, before first dosing, and on the first day of each cycle. Consent must be given to the use of effective contraceptive methods to prevent pregnancy. No egg donation. And willing to take effective contraceptive methods to prevent pregnancy after signing the informed consent until 90 days after the last dosing of the study.\n\nExclusion Criteria:\n\n1. During previous treatment with HER2-targeted drugs such as trastuzumab or pertuzumab, T-DM1, vedicitumab or Enhertu, as well as topoisomerase I inhibitors (such as irinotecan), grade 3 aes (including but not limited to infusion reactions or allergic reactions) that were determined to be treaty-related or of unknown drug relationship, or L after treatment VEF \\\u003C 50%;\n2. Participants who had previously received doxorubicin with cumulative dose \\> 360 mg\u002Fm2 or equivalent anthracyclines;\n3. Before the first administration of the investigational drug, AE (CTCAE5.0) caused by previous antitumor therapy still had grade 1, except for the following cases: a. Hair loss; b Pigmentation; c. Patients with distal toxicity caused by chemotherapy and radiotherapy who can not be further recovered by judgment;\n4. primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or a history of epilepsy. Patients with asymptomatic or asymptomatic central nervous system metastases under clinical control or who have symptoms but are judged to be stable by the investigators can be included, provided that the following conditions are met :a. The clinical symptoms were stable ≥4 weeks before the first dose. b. Brain MRI enhancement showed no evidence of progression of central nervous system disease within 4 weeks prior to initial administration; c. Antiepileptic drugs, hormones and other drugs have been stopped ≥2 weeks before the first administration;\n5. Major surgical procedures were performed within 28 days prior to the first use of the study drug, or if postoperative complications persist after 21 days;\n6. Subjects who have had a severe infection within 4 weeks prior to first dosing, or who have any signs and symptoms of active infection within 2 weeks prior to first dosing;\n7. Subjects who have not been treated or are being treated for tuberculosis, including but not limited to tuberculosis (those who have been treated with standardized anti-tuberculosis therapy and have been confirmed cured by the investigator), a history of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency diseases, or a history of organ transplantation;\n8. there are infected with the following diseases: active hepatitis B virus infection \\[hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus deoxyribonucleic acid (HBV-DNA) test \\>200 IU\u002Fml or 103 copies \u002Fml (or \\> the normal high value of the study center detection)\\]; Hepatitis C virus infection \\[HCV antibody and viral ribonucleic acid (HCV-RNA) test positive\\]; Treponema pallidum antibody positive and RPR positive;\n9. Patients with symptomatic congestive heart failure (NYHA grade II to IV) or severe arrhythmias requiring treatment (12-lead ECG QTc extension of 450 ms \\[male\\], 470 ms \\[female\\]), myocardial infarction, unstable angina in the last 6 months. Except atrial fibrillation or paroxysmal supraventricular tachycardia;\n10. Patients with a history of non-infectious pneumonia requiring glucocorticoid therapy or with current interstitial lung disease;\n11. the presence of any other serious underlying medical conditions (e.g. Gilbert's syndrome, uncontrolled diabetes, uncontrolled hypertension, active gastric ulcers, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation and coagulation disorders), psychiatric\u002Fpsychological\u002Ffamily factors that the investigator determines may influence screening, treatment, and follow-up. Affect compliance or put patients at high risk for treatment-related complications;\n12. The previous anti-tumor therapy (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization, etc.) is less than 28 days from the first study (or if the half-life of the drug is 5 times shorter than 28 days, the sponsor and the researcher shall decide whether to include it according to the specific analysis of the specific circumstances). Note that castration for prostate cancer and bisphosphonate or dinomumab for osteoporosis are permitted. Patients whose previous palliative radiotherapy was less than 7 days removed from the first study, or whose previous wide-field radiotherapy was less than 28 days removed from the first study, or who had not recovered from the side effects of radiotherapy as determined by the investigators;\n13. Therapeutic radiopharma use must be discontinued 8 weeks before the first study administration;\n14. Known allergy or intolerance to the investigational drug or its excipients;\n15. Pregnant or lactating women;\n16. Subjects considered unsuitable for participation in this study by the researcher.",{"count":118,"type":21},216,[76,52],"This study is a multicenter, open, exploratory Phase Ib\u002FIIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+\u002FFISH+, and IHC2+\u002FFISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the \"3+3\" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study.",[79],"2025-08-11",{"date":124,"type":32},"2025-08-13",{"date":126,"type":32},"2024-05-08",{"date":128,"type":21},"2026-12-09",{"name":38,"class":39},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":137,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":65},"100525603","phase-2-bat1308-combined-with-platinum-based-chemotherapy-bevacizumab-for-pdl1-positive-cps-1-cervical-cancer-100525603","NCT06123884","BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer","A Phase II\u002FIII Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy ± Bevacizumab As First-Line Therapy for PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer","inclusion criteria：\n\n1. Female patients, aged ≥18 years to ≤70 years, who voluntarily sign the informed consent form;\n2. With persistent, recurrent or metastatic (the Federation International of Gynecology and Obstetrics \\[FIGO\\] Stage IVB) cervical cancer confirmed histologically (pathological reports required), including pathological types of squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma and clear-cell renal-cell carcinoma, not amenable to radical surgery and\u002For radical radiotherapy or radiochemotherapy, with no prior systemic anti-tumor therapy for persistent, recurrent or metastatic cervical cancer;\n3. Subjects should be positive for PD-L1 expression (CPS ≥ 1) in tumor specimens by the central laboratory. Subjects should provide sufficient formalin-fixed paraffin-embedded (FFPE) specimens or sections (6 sections recommended, not less than 3 sections), and be willing to undergo a tumor tissue biopsy for PD-L1 testing when necessary. The archival tissues must be representative tumor specimens collected within three years or unstained continuous sections of FFPE tumor tissues freshly resected within six months, and relevant pathological reports of the aforementioned specimens must also be provided. Both surgical resection and biopsy are acceptable methods for acquiring fresh tissue specimens; fine-needle aspiration and liquid-based cytology (TCT) samples (i.e., samples lacking complete tissue structures and providing only cell suspension and\u002For cell smears) are not acceptable; decalcified bone metastasis tumor tissue specimens are not acceptable;\n4. At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapies can only be considered as non-target lesions, unless unequivocal progression of the lesion occurs or the tumor activity of the lesion is confirmed by biopsy and the lesion is measurable\n5. Life expectancy ≥12 weeks as evaluated by the investigator;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1;\n7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and are willing to take effective birth control\u002Fcontraceptive methods to prevent pregnancy during the study until 6 months after the last dose of the study drug. Postmenopausal women must have amenorrhea for at least 12 months before they are considered as women of non-childbearing potential.\n\n9\\. Able to understand trial requirements, willing and able to comply with the trial and follow-up procedures.\n\nexclusion criteria：\n\n1. Subjects with other pathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.;\n2. Pregnant or lactating women;\n3. Prior radiotherapy within 14 days before the first dose. Except for palliative area radiotherapy for bone metastases for which pain cannot be effectively controlled by systemic therapy or local pain relief (radiotherapy area \\\u003C 5% of bone marrow area); prior chemotherapeutic agents for increasing the sensitization to radiotherapy within 14 days before the first dose; prior use of traditional Chinese patent medicines or treatment with anti-tumor related functions as specified in the NMPA-approved package inserts within 14 days before the first dose, or Chinese herbal medicines for anti-tumor purposes clearly documented in the medical record ;\n4. Patients who received live\u002Fattenuated vaccines and mRNA vaccines within 4 weeks prior to screening or scheduled to receive those vaccines during the study period;\n5. Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or therapies that target immune co-stimulatory molecules (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.);\n6. AEs caused by prior anti-tumor therapy that are still \\> Grade 1 (as per CTCAE v5.0) before the first dose of the study drug (except for AEs, such as alopecia, fatigue, etc., that cannot be recovered to ≤ Grade 1 and will remain stable for a long time as judged by the investigator based on actual clinical situations, except for Grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy); patients who previously experienced ≥ Grade 3 irAEs or discontinued immunotherapy due to irAEs of any grade;\n7. Active leptomeningeal disease or poorly controlled brain metastases. Patients with suspected or confirmed brain metastases are allowed to be enrolled if they have no obvious symptoms and the results of imaging examinations performed at least 28 days before the first dose of the study drug showed stable disease and no treatment (e.g., radiotherapy, surgery, or corticosteroid treatment) is required to control the symptoms of brain metastases within 28 days before the first dose of the study drug;\n8. Patients who underwent major organ surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before the first dose of the study drug, or those who require elective surgery during the trial period;\n9. Subjects with serious infections within 4 weeks before the first dose, including but not limited to the infection-related complications, bacteremia and severe pneumonia requiring hospitalization; subjects with active infection before the first dose are excluded;\n10. Patients with the following infectious diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection \\[hepatitis B surface antigen (HBsAg) positive, and the result for hepatitis B virus deoxyribonucleic acid (HBV-DNA) test \\> 500 IU\u002Fml or 103 copies\u002Fml or above the upper limit of normal at the testing institution\\]; hepatitis C virus infection \\[anti-HCV antibodies and hepatitis C virus ribonucleic acid (HCV-RNA) test positive\\]; Treponema pallidum antibody positive and rapid plasma reagin (RPR) positive;\n11. Subjects with tuberculosis untreated or under treatment, including but not limited to pulmonary tuberculosis; patients whose tuberculosis was cured after standardized anti-tuberculosis treatment as confirmed by the investigator may be included;\n12. Subjects with known history of severe allergy or prior ≥ Grade 3 allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, and any component of the investigational drug;\n13. Known to have any contraindication to cisplatin\u002Fcarboplatin or paclitaxel, or allergy to any of their components;\n14. Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent insertion as judged by the investigator;\n15. Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n16. Patients with active or potentially recurrent autoimmune disease (excluding patients with vitiligo, autoimmune thyroid disorder that can be treated with hormone replacement therapy, or type 1 diabetes mellitus);\n17. Patients who required systemic treatment with glucocorticoid (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of the study drug, except for the following situations: ① topical, ocular, intra-articular, nasal, and inhaled glucocorticoid therapy; ② short-term use of glucocorticoid for prophylaxis (e.g., prevention of contrast allergy);\n18. Subjects with a history of noninfectious pneumonitis requiring glucocorticoid therapy within 1 year before the first dose or with current interstitial lung disease;\n19. History of severe cardiovascular and cerebrovascular disorders, including but not limited to: ① New York Heart Association (NYHA) Class II or above cardiac failure or left ventricular ejection fraction (LVEF) \\\u003C50%; ② Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive cardiac failure, aortic dissection, stroke, or other Grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first dose; ④ Clinically uncontrollable hypertension (defined in this protocol as systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg despite the use of antihypertensive therapy);","FEMALE","70 Years",{"count":140,"type":21},526,[52,24],"Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer",[144],"Cervical Cancer","2025-02-05",{"date":147,"type":32},"2025-02-10",{"date":149,"type":32},"2023-12-13",{"date":151,"type":21},"2027-01",{"name":38,"class":39},""]