[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Pharmaceuticals Holding Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":285},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,61,81,102,124,144,164,186,205,225,247,266],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580579","phase-1-a-clinical-study-of-sph9788-tablets-in-healthy-chinese-subjects-100580579",false,"NCT06839131","A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.","A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SPH9788 Tablet in Chinese Healthy Subjects.","Inclusion Criteria:\n\n1. Healthy male and female subjects aged from 18 to 45 years;\n2. Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg\u002Fm2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;;\n3. Subjects who voluntarily participate and sign informed consent form;\n4. Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;\n5. Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.\n\nExclusion Criteria:\n\n1. Medical history (current or past) that in the investigator's judgment may interfere with trial participation;\n2. Surgical\u002Fmedical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;\n3. Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;\n4. Use of any prescription\u002Fnon-prescription medications (including herbal products) within 2 weeks prior to dosing;\n5. Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;\n6. Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;\n7. Substance abuse history within 1 year prior to screening or positive urine drug screen;\n8. Alcohol abuse history within 1 year or positive alcohol breath test;\n9. Smoking ≥5 cigarettes\u002Fday on average during 3 months prior to screening;\n10. Pregnant or lactating women;\n11. Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs;\n12. Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},94,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.",[28],"Healthy Participants","RECRUITING","2026-04-29",{"date":32,"type":33},"2026-05-05","ACTUAL",{"date":35,"type":33},"2025-03-02",{"date":37,"type":22},"2026-12-31",{"name":39,"class":40},"Shanghai Pharmaceuticals Holding Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":41},"100553229","early-phase-1-a-clinical-study-of-sph7854-granules-in-healthy-subjects-100553229","NCT06483373","A Clinical Study of SPH7854 Granules in Healthy Subjects.","A Single and Multiple Dose-escalation, and Food Effects of Phase I Clinical Study to Evaluate the Tolerability\u002FSafety\u002FPharmacokinetics of SPH7854 Granules in Healthy Subjects.","Inclusion Criteria:\n\n1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；\n2. Healthy volunteers;\n3. Before receiving the investigational drug, the examination results were normal or clinically insignificant;\n4. Subjects who have no fertility plan\u002Fsperm donation\u002Fegg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.\n\nExclusion Criteria:\n\n1. Female subjects who are breastfeeding or have positive pregnancy results;\n2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;\n3. Subjects suffering from allergic diseases or having a history of severe allergies;\n4. Subjects who took the drug or food prohibited by the protocol prior to the first dose;\n5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;\n6. Other circumstances that meet the protocol exclusion criteria.",{"count":50,"type":22},111,[52],"EARLY_PHASE1","To evaluate the safety of SPH7854 in healthy subjects.",[55],"Inflammatory Bowel Disease",{"date":32,"type":33},{"date":58,"type":33},"2024-05-28",{"date":37,"type":22},{"name":39,"class":40},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":79,"locationsCount":80},"100532541","phase-1-a-clinical-study-of-t3011-in-combination-with-pd-1pd-l1-inhibitors-in-subjects-with-advanced-solid-tumors-100532541","NCT06214143","A Clinical Study of T3011 in Combination With PD-1\u002FPD-L1 Inhibitors in Subjects With Advanced Solid Tumors","A Single-arm, Multi-center Phase Ib\u002FIIa Clinical Study to Evaluate the Tolerability, Safety, and Initial Efficacy of T3011 Herpesvirus Injection Combined With PD-1\u002FPD-L1 Inhibitors in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects with advanced solid tumors;\n2. At least one measurable lesion;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n4. Expected survival \\> 12 weeks;\n5. Laboratory inspection meets the requirements;\n6. For women of childbearing potential, the serum pregnancy test results must be negative prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose;\n7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period;\n8. Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.\n\nExclusion Criteria:\n\n1. Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;\n2. Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.\n3. At screening, subjects with a history or evidence of high risk cardiovascular disease;\n4. Subjects with persistent or active infection requiring intravenous anti-infective therapy;\n5. Subjects with autoimmune diseases or a history of autoimmune diseases;\n6. Subjects with known psychiatric disorders that may affect trial compliance;\n7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment;\n8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;\n9. Subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; Subjects who have received any tumor vaccine in the past;\n10. Subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period;\n11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;\n12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;\n13. The investigator considers it inappropriate to participate in this study.",{"count":69,"type":22},68,[25,71],"PHASE2","This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1\u002FPD-L1 inhibitors in subjects with advanced solid tumors",[74],"Advanced Solid Tumors",{"date":32,"type":33},{"date":77,"type":33},"2024-01-11",{"date":37,"type":22},{"name":39,"class":40},22,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},"100506281","phase-2-efficacy-and-safety-of-sph4336-in-combination-with-endocrine-therapy-in-breast-cancer-patients-with-brain-metastases-100506281","NCT05872347","Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.","A Phase II Study of SPH4336 in Combination With Endocrine Therapy in HR-positive, HER2-negative Breast Cancer Patients With Brain Metastases.","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).\n2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies.\n5. At least one measurable lesion .\n6. Laboratory test results meet the relevant requirements for organ function.\n7. Subjects who agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. Patients unsuitable for endocrine therapy at the investigator's discretion.\n3. Have a History of other malignancies prior to the start of study treatment.\n4. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.\n5. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.\n6. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.\n7. Pregnant or lactating women.\n8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; QTcF≥ 470 ms; left ventricular ejection fraction ≤ 50%.\n9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n10. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or \\> 10(4) copies\u002FmL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.\n11. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.\n12. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.\n13. Presence of uncontrolled infections before the start of study treatment.\n14. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.\n15. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.","FEMALE","75 Years",{"count":91,"type":22},52,[71],"This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.",[95],"Breast Cancer Brain Metastases",{"date":32,"type":33},{"date":98,"type":33},"2023-09-19",{"date":37,"type":22},{"name":39,"class":40},25,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100492015","phase-2-efficacy-and-safety-of-lt3001-on-treating-the-acute-ischemic-stroke-100492015","NCT05686642","Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke","A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in Subjects With Acute Ischemic Stroke (AIS)","Inclusion Criteria:\n\n1. Subjects aged between 18 and 80 years at screening;\n2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;\n\n4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.\n\nExclusion Criteria:\n\n1. Subjects have received or plan to receive endovascular treatment and\u002For intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;\n2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;\n3. Neurological signs have improved rapidly and spontaneously at screening;\n4. Subjects who have used or are using protocol-prohibited medications after the onset;\n5. Subjects with pre-stroke disability;\n6. Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment;\n7. Massive infarction on imaging;\n8. Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;\n9. Systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after active antihypertensive therapy;\n10. Acute hemorrhage tendency;\n11. Blood glucose level \\\u003C 50 mg\u002FdL or \\> 400 mg\u002FdL;\n12. Active visceral hemorrhage;\n13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results;\n14. International normalized ratio \\> 1.7 or prothrombin time \\> 15 s;\n15. Subjects with a history of serious hypersensitivity;\n16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;\n17. Subjects who underwent any major surgery before screening;\n18. Subjects with a history of active digestive ulcer before screening;\n19. Subjects who experienced hemorrhagic disease before screening;\n20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;\n21. Serious hepatic impairment or serious renal insufficiency;\n22. Subjects who have participated in another investigational study and used investigational product before screening;\n23. Other conditions unsuitable for participation in this study determined by the Investigator.","80 Years",{"count":111,"type":22},300,[71],"This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke",[115],"Acute Ischemic Stroke",{"date":117,"type":33},"2026-04-30",{"date":119,"type":33},"2023-04-06",{"date":121,"type":22},"2026-12-12",{"name":39,"class":40},28,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100458087","early-phase-1-sph5030-tablets-in-subjects-with-advanced-her2-positive-solid-tumors-100458087","NCT05245058","SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors","Inclusion Criteria:\n\n1. ECOG performance status of 0 to 1.\n2. Life expectancy of more than 3 months.\n3. At least one measurable lesion exists.(RECIST 1.1)\n4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.\n5. Required laboratory values including following parameters:\n\n   ANC: ≥ 1.5 x 109\u002FL Plt count: ≥ 90x 109\u002FL Hb: ≥ 90 g\u002FL TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL\u002Fmin\n6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.\n7. Blood pregnancy test was negative within 3 days prior to first dose.\n\nExclusion Criteria:\n\n1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.\n2. Known active infection within 2 weeks prior to baseline.\n3. Subjects with third space fluid that can not be controled.\n4. Subjects with uncontrolled or severe cardiovascular disease.\n5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.\n6. Subjects with severe lung disease.\n7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.\n8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.\n9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.\n10. Uncured other tumors within 5 years.\n11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.\n12. Evidence of chronic active hepatitis B or C\n13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.\n14. Receive any live or attenuated live vaccine within 28 days prior to baseline.\n15. Evidence of severe allergies.\n16. Evidence of alcohol or drug abuse.\n17. Evidence of neurological or psychiatric disorders.",{"count":132,"type":22},150,[52],"To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors",[136],"HER2-positive Advanced Solid Tumors",{"date":32,"type":33},{"date":139,"type":33},"2022-01-21",{"date":141,"type":22},"2026-12-21",{"name":39,"class":40},17,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100450428","early-phase-1-clinical-study-of-b001-injection-in-subjects-with-neuromyelitis-optic-spectrum-disorder-nmosd-100450428","NCT05145361","Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD)","A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD)","Inclusion Criteria:\n\n1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening\n2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening\n3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening\n4. Age 18 to 70 years, inclusive at the time of informed consent\n\nExclusion Criteria:\n\n1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline.\n2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration.\n3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic\u002Fhematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal\u002Furologic disease, digestive system disease, congenital or acquired severe immunodeficiency.\n4. Known active infection within 3 months prior to baseline\n5. Pregnancy or lactation.\n6. History of severe allergic reaction to a biologic agent\n7. Evidence of chronic active hepatitis B or C\n8. Evidence of active tuberculosis\n9. Following laboratory abnormalities at screening\\*:\n\n   1. White blood cells (WBC) \\\u003C4.0 x10\\^3\u002Fmicroliter (μL)\n   2. Absolute neutrophil count (ANC)\n   3. Absolute lymphocyte count \\\u003C0.5 x10\\^3\u002FμL\n   4. Platelet count \\\u003C80 x 10\\^9\u002F L\n   5. Aspartate aminotransferase (AST) or alanine aminotransferase\n10. History of drug or alcohol abuse within 6 months prior to baseline\n11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline\n12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.",{"count":152,"type":22},45,[52],"The objectives of this phase Ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of B001 in subjects with aquaporin-4 antibody (AQP4-IgG) positive NMOSD.",[156],"NMO Spectrum Disorder",{"date":32,"type":33},{"date":159,"type":33},"2022-04-07",{"date":161,"type":22},"2026-12-15",{"name":39,"class":40},4,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100532542","phase-1-a-clinical-study-of-t3011-in-subjects-with-advanced-melanoma-100532542","NCT06214156","A Clinical Study of T3011 in Subjects With Advanced Melanoma","A Phase Ib\u002FIIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma","Inclusion Criteria:\n\n1. Subjects with advanced melanoma;\n2. At least one measurable lesion;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n4. Expected survival \\> 12 weeks;\n5. Laboratory inspection meets the requirements;\n6. For women of childbearing potential, the serum pregnancy test results must be negative within 7 days prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose;\n7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period;\n8. Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.\n\nExclusion Criteria:\n\n1. Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;\n2. Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.\n3. At screening, subjects with a history or evidence of high risk cardiovascular disease;\n4. Subjects with persistent or active infection requiring intravenous anti-infective therapy;\n5. Subjects with autoimmune diseases or a history of autoimmune diseases;\n6. Subjects with known psychiatric disorders that may affect trial compliance;\n7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment;\n8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;\n9. Subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; Subjects who have received any tumor vaccine in the past;\n10. Subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period;\n11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;\n12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;\n13. The investigator considers it inappropriate to participate in this study.",{"count":172,"type":22},42,[25,71],"This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.",[176],"Advanced Melanoma","2026-01-12",{"date":179,"type":33},"2026-01-14",{"date":181,"type":33},"2024-01-26",{"date":183,"type":22},"2026-09-30",{"name":39,"class":40},7,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":203,"locationsCount":204},"100511806","phase-1-a-study-to-efficacy-and-safety-of-sph4336-monotherapy-or-in-combination-with-cadonilimab-in-patients-with-advanced-solid-tumors-100511806","NCT05944224","A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.","A Randomized, Open-label, Phase Ib\u002FIIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated\u002FDedifferentiated Liposarcoma.","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and sign informed consent.\n2. Expected survival ≥3 months.\n3. Patients with advanced solid tumors (including advanced Well differentiated\u002Fdedifferentiated liposarcoma) who cannot be treated by radical surgery\u002Fother local treatment.\n4. According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.\n5. The laboratory test results meet the organ function requirements before starting the study treatment.\n6. Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss\u002Fpigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.\n7. Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.\n\nExclusion Criteria:\n\n1. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.\n2. Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.\n3. Had a history of other malignancies before starting the study.\n4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.\n5. Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.\n6. Previous history of organ transplantation.\n7. Before starting the study, HBsAg positive patients with HBV DNA \\> 500IU\u002F mL or 2500 copies \u002FmL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.\n8. Accompanied by any other serious, progressive, or uncontrolled disease.\n9. Subjects with a known history of immune-related adverse events that the investigator determined could not be included.\n10. History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.\n11. Women who are pregnant or breastfeeding.\n12. Any other reason for which patients are ineligible for the study as assessed by the investigator.",{"count":194,"type":22},63,[25,71],"This is a randomized, Open-label, Phase Ib\u002FIIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.",[74],{"date":199,"type":33},"2026-01-13",{"date":201,"type":33},"2023-10-17",{"date":37,"type":22},{"name":39,"class":40},16,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":89,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":80},"100505369","phase-2-safety-and-efficacy-of-sph4336-in-combination-with-endocrine-therapy-in-the-treatment-of-locally-advanced-or-metastatic-breast-cancer-100505369","NCT05860465","Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer","A Phase II\u002FIII Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4\u002F6 Inhibitor Combined With Endocrine Therapy","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).\n2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies.\n5. At least one measurable lesion.\n6. Laboratory test results meet the relevant requirements for organ function.\n7. Subjects who agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. Patients unsuitable for endocrine therapy at the investigator's discretion.\n3. History of other malignancies prior to the start of study treatment.\n4. Patients with known metastases to central nervous system.\n5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.\n6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.\n7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.\n8. Pregnant or lactating women.\n9. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.\n10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n11. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or \\> 104 copies\u002FmL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.\n12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.\n13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.\n14. Presence of uncontrolled infections before the start of study treatment.\n15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.\n16. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.",{"count":213,"type":22},254,[71,215],"PHASE3","This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4\u002F6 inhibitor combined with endocrine therapy.",[218],"Locally Advanced or Metastatic Breast Cancer",{"date":179,"type":33},{"date":221,"type":33},"2023-09-08",{"date":223,"type":22},"2026-12-30",{"name":39,"class":40},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100553543","phase-1-a-clinical-study-of-sph7485-tablets-in-the-treatment-of-advanced-solid-tumors-100553543","NCT06487455","A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.","An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced solid tumors；\n2. At least one extracranial measurable lesion;\n3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;\n4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;\n5. Life expectancy≥3 months;\n6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;\n7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;\n8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.\n\nExclusion Criteria:\n\n1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;\n2. Subjects who have received previous drugs with the same target;\n3. Subjects with active infections requiring systemic treatment;\n4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;\n5. Subjects with uncontrolled or severe cardiovascular disease;\n6. Severe lung disease;\n7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;\n8. Subjects taking strong\u002Fmoderate inhibitors or inducers of CYP3A4;\n9. Subjects who use or require long-term use of hormonotherapy before screening;\n10. Subjects who have had other malignancies within the past 5 years;\n11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;\n12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;\n13. Abnormal virological examination during screening; History of immune deficiency;\n14. Uncontrolled systemic diseases;\n15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;\n16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;\n17. Subjects with a history of severe allergy or known allergy to this product and its excipients;\n18. Subjects who cannot follow the study protocol to complete the required study visit and dosing;\n19. Subjects with a history of alcohol or drug abuse;\n20. Lactating female patients;\n21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;\n22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.",{"count":233,"type":22},170,[25],"To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.",[237],"Advanced Solid Tumor","2025-08-15",{"date":240,"type":33},"2025-08-17",{"date":242,"type":33},"2024-08-06",{"date":244,"type":22},"2027-12-31",{"name":39,"class":40},6,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":264,"locationsCount":265},"100549482","phase-2-a-clinical-study-of-sph5030-tablets-in-the-treatment-of-her2-positivemutated-biliary-tract-or-colorectal-cancer-patients-100549482","NCT06434597","A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer Patients.","A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer.","Inclusion Criteria:\n\n1. Metastatic and\u002For unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and\u002For unresectable advanced biliary tract carcinoma\n2. HER2 positive or HER2 gene mutation;\n3. Meet the requirements of previous treatment;\n4. ECOG performance status of 0 or 1；\n5. Expected survival ≥ 3 months;\n6. No serious abnormalities in hematopoietic function, liver or kidney function;\n7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;\n8. Fully informed subjects who voluntarily sign the ICF.\n\nExclusion Criteria:\n\n1. Subjects who have previously received anti-HER2 molecular targeted therapy;\n2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;\n3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;\n\n5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.",{"count":255,"type":22},60,[71],"To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive\u002Fmutated biliary tract OR colorectal cancer.",[259],"Biliary Tract or Colorectal Cancer With Her2-positive\u002FMutated",{"date":240,"type":33},{"date":262,"type":33},"2024-07-17",{"date":37,"type":22},{"name":39,"class":40},30,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":89,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100496473","phase-2-phase-iiiii-study-of-sph4336-combined-with-letrozole-vs-placebo-combined-with-letrozole-in-first-line-treatment-of-breast-cancer-100496473","NCT05744687","Phase II\u002FIII Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer","Randomized, Double-blind, Placebo-controlled, Phase II\u002FIII Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).\n2. Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.\n3. ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative confirmed by tumor histopathology and molecular pathology.\n6. No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries\u002Fother local therapies.\n7. At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.\n8. Postmenopausal or premenopausal\u002Fperimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.\n9. Laboratory test results before randomization meet the relevant requirements for organ function.\n\nExclusion Criteria:\n\n1. Prior treatment with any CDK4\u002F6 （Cyclin dependent kinase）inhibitor.\n2. Inflammatory breast cancer.\n3. Patients unsuitable for endocrine therapy at the investigator's discretion.\n4. History of other malignancies within 5 years prior to the start of study treatment.\n5. Patients with known central nervous system metastases.\n6. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.\n7. Having undergone a surgery within 28 days prior to the start of study treatment, and hasn't yet recovered from adverse reactions of the surgery.\n8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA( New York Heart Association) Class ≥II; QTcF≥ 470 ms; LVEF(Left Ventricular Ejection Fractions)≤ 50%.\n9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n10. Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.\n11. Hepatitis B surface antigen positive and HBV(Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or 104 copies\u002FmL; HCV(hepatitis C virus) antibody positive and HCV RNA positive; or known HIV infection.\n12. Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.\n13. History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.\n14. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.\n15. Uncontrolled infections within 2 weeks before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.\n16. Pregnant or lactating women.\n17. Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.\n18. Presence of other diseases judged by the investigator that the risks of receiving the study treatment outweigh its benefits, or any other reason for which patients are ineligible for the study as assessed by the investigator and the sponsor.",{"count":274,"type":22},374,[71,215],"This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer",[218],{"date":240,"type":33},{"date":280,"type":33},"2023-04-24",{"date":282,"type":22},"2026-05-31",{"name":39,"class":40},9,""]