[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"RemeGen Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":577},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,43,65,89,108,129,149,169,192,212,232,251,273,294,316,342,366,392,415,437,458,485,506,531,555],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100628477","phase-2-a-phase--clinical-trial-of-rc148-plus-chemotherapy-as-1l-therapy-for-unresectable-or-metastatic-colorectal-cancer-100628477",false,"NCT07462143","A Phase Ⅱ\u002FⅢ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer","A Randomized, Multicenter, Phase Ⅱ\u002FⅢ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.\n2. Aged 18-75 years old (including 18 years old and 75 years old).\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n4. Expected survival period ≥ 12 weeks.\n5. At least one measurable lesion according to RECIST v1.1 criteria.\n6. Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.\n7. Subjects must be able to provide tumor tissue samples for biomarker detection.\n8. Adequate bone marrow, liver, kidney, and coagulation function.\n9. Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.\n\nExclusion Criteria:\n\n1. Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).\n2. Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.\n3. Subjects with brain metastases.\n4. Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.\n5. Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.\n6. Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.\n7. Subjects with acute, chronic, or symptomatic infections.\n8. Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.\n9. Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and\u002For fistula, or clinical symptoms of gastrointestinal obstruction.\n10. Subjects with severe arterial\u002Fvenous thromboembolic events within 6 months before randomization.\n11. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.\n12. Presence of symptomatic or intervention-requiring third-space effusions.\n13. Subjects with active or previously diagnosed autoimmune diseases that may recur.\n14. History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.\n15. Subjects who are pregnant, lactating, or planning to become pregnant.","ALL","18 Years","75 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","This is a Phase Ⅱ\u002FⅢ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)",[29],"Colorectal (Colon or Rectal) Cancer","RECRUITING","2026-05-18",{"date":33,"type":34},"2026-05-22","ACTUAL",{"date":36,"type":34},"2026-05-12",{"date":38,"type":22},"2030-12-31",{"name":40,"class":41},"RemeGen Co., Ltd.","INDUSTRY",19,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100624964","phase-3-rc148-plus-platinum-based-chemotherapy-vs-tislelizumab-plus-platinum-based-chemotherapy-for-first-line-squamous-non-small-cell-lung-cancer-sqnsclc-100624964","NCT07416474","RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)","Randomized, Double-Blind, Multicenter Phase III Study of RC148 in Combination With Platinum-Based Chemotherapy Versus Tislelizumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily participate in the study and signed the Informed Consent Form (ICF).\n2. Be willing to and able to participate in the trial and comply with the follow up procedures;\n3. Male or female, aged 18-75 years.\n4. Expected survival ≥ 3 months.\n5. ECOG PS score 0 or 1.\n6. Histopathologically or cytologically confirmed locally advanced or metastatic NSCLC not eligible for curative treatment.\n7. No prior systemic anti-tumor treatment for advanced or metastatic squamous NSCLC.\n8. Sufficient cardiac, bone marrow, hepatic, renal, and coagulation function.\n9. Female participants must be postmenopausal, surgically sterilized, or of childbearing potential with a negative blood pregnancy test within 7 days before the first dose. Female participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate oocytes or breastfeed during this period. Male participants must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must not donate sperm during this period.\n10. At least one measurable lesion outside of the brain according to the RECIST v1.1 criteria.\n11. A PD-L1 expression test report that meets the requirements must be provided before enrollment.\n\nExclusion Criteria:\n\n1. Histopathologically or cytologically confirmed non-squamous non-small cell lung cancer.\n2. Squamous NSCLC with known EGFR sensitive mutations and ALK fusions; squamous NSCLC with known driver gene for which first-line approved treatment options exist.\n3. Presence of active brain metastases.\n4. Imaging at screening shows obvious tumor necrosis and cavitation, and the investigator judges that participation in the study will cause bleeding risk.\n5. Chest radiotherapy \\> 30Gy within 6 months before randomization; palliative local treatment for non-target lesions within 2 weeks before randomization; non-specific immunomodulatory treatment within 2 weeks before randomization; Chinese herbal medicine or proprietary Chinese medicine treatment with anti-tumor indications within 1 week before randomization.\n6. History of immunotherapy. Note: For adjuvant\u002Fneoadjuvant phases or curative radiotherapy\u002Fchemoradiotherapy, PD-L1\u002FPD-1 antibody therapy should be administered only if recurrence or metastasis occurs more than 12 months after the completion of the last medication.\n7. Prior systemic anti-tumor treatment other than chemotherapy and PD-1\u002FPD-L1 antibodies.\n8. Systemic treatment with corticosteroids or other immunosuppressive drugs within 2 weeks before randomization.\n9. Use of any live or attenuated live vaccines within 4 weeks before randomization, or planned during the study.\n10. Participation in other clinical trials within 4 weeks before randomization.\n11. Major surgery, interventional therapy, or severe trauma within 4 weeks before randomization, or planned major surgery during the study; core needle biopsy or other minor surgery within 7 days before randomization.\n12. Participants with history of severe coagulation dysfunction or current intake of anticoagulant drugs.\n13. Toxic reactions from prior anti-tumor treatment have not recovered to grade 0-1 as defined by CTCAE version 6.0.\n14. Severe acute or chronic infections.\n15. Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 4 weeks before randomization; or presence of severe esophagogastric varices or epistaxis.\n16. Severe arterial\u002Fvenous thrombotic events or cerebrovascular accidents within 6 months before randomization.\n17. Active or clinically significant heart disease.\n18. Past or current interstitial lung disease, drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or clinical manifestations or high-risk factors suspected of interstitial lung disease.\n19. History of gastrointestinal perforation and\u002For fistula, history of gastrointestinal obstruction within 6 months before randomization.\n20. Presence of systemically diseases that are not stably controlled as judged by the investigator.\n21. Active or history of autoimmune diseases with potential for recurrence.\n22. Past history of other acquired or congenital immunodeficiency diseases or organ transplantation.\n23. Known hypersensitivity or delayed-type hypersensitivity to certain components of the study drug or similar drugs.\n24. Presence of symptomatic or intervention-requiring third-space effusions.\n25. Other malignant tumors within 5 years before the start of study drug administration, except for malignant tumors that are expected to be cured after treatment.\n26. Poor compliance and expected inability to cooperate with the completion of trial procedures.\n27. Past or current history of any other diseases, abnormal physical examination findings, or abnormal laboratory examination findings that, in the investigator's judgment, reasonably suggest that the participant has a disease or condition unsuitable for the use of the study drug.\n28. Local or systemic diseases not caused by malignant tumors, or diseases or symptoms secondary to tumors.\n29. For participants who have used PD-1\u002FL1 inhibitors, prior occurrence of grade 3 or above irAE related to immunotherapy, irAE leading to permanent discontinuation of treatment, grade 2 immune-related cardiotoxicity, or irAE of any grade involving the nervous system or eyes; prior occurrence of adverse events requiring treatment with immunosuppressive drugs other than corticosteroids, or recurrence of adverse events during previous immunotherapy requiring systemic use of corticosteroids again.",{"count":51,"type":22},574,[26],"This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous NSCLC who have not received first-line treatment. Participants will: Take RC148 or Tislelizumab combined with platinum-based chemotherapy until the end of the research.",[55],"Non-Small Cell Lung Cancer","2026-04-15",{"date":58,"type":34},"2026-04-20",{"date":60,"type":34},"2026-04-03",{"date":62,"type":22},"2029-11-30",{"name":40,"class":41},66,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100634299","phase-1-a-iii-phase-clinical-study-to-evaluate-the-safety-and-efficacy-of-rc288-in-the-treatment-of-solid-tumors-100634299","NCT07537881","A I\u002FII Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors","A Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of RC288 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor.","Inclusion Criteria:\n\n1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;\n2. Age between 18 and 75 years (including 18 and 75 years);\n3. ECOG PS score of 0 or 1;\n4. Expected survival ≥12 weeks;\n5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;\n6. Sufficient bone marrow, liver, kidney, and blood clotting function\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or intending to become pregnant subjects.\n2. Subjects with brain metastases.\n3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v6.0 Grade 1.\n4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.\n5. Subjects with acute, chronic, or symptomatic infections.\n6. Subjects with uncontrolled cardiovascular diseases.\n7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.\n8. History of underlying pulmonary disease.\n9. Subjects with a history of cirrhosis (Child-Pugh B or C class).\n10. Clinically significant gastrointestinal disease.\n11. Subjects with uncontrolled diabetes (HbA1c ≥ 10%).\n12. Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening.\n13. Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation.\n14. History of arterial\u002Fvenous thromboembolic events within 6 months prior to the first dose.\n15. Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods.\n16. History of active autoimmune disease requiring systemic therapy within the past 2 years.\n17. History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy.\n18. History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n19. History of or current poorly controlled psychiatric disorder.\n20. Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures.\n21. Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk.\n22. Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and\u002For uncertainty in survival assessment.",{"count":73,"type":22},326,[75,25],"PHASE1","The primary objective is to evaluate the safety and tolerability of RC288; determine the maximum tolerated dose (MTD) and\u002For maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 at the RP2D dose;",[78],"Solid Tumors","NOT_YET_RECRUITING","2026-04-12",{"date":82,"type":34},"2026-04-17",{"date":84,"type":22},"2026-04-30",{"date":86,"type":22},"2030-06-30",{"name":40,"class":41},1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":88},"100631004","phase-3-phase-iii-clinical-trial-of-telitacicept-injection-in-the-treatment-of-patients-with-connective-tissue-disease-related-interstitial-lung-disease-100631004","NCT07495033","Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease","Inclusion Criteria:\n\n1. Voluntary informed consent provided;\n2. Male or female aged ≥ 18 years old;\n3. Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SjD) , Systemic sclerosis（SSc）,or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria;\n4. Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WL-ILD);\n5. During screening, FVC%Pred ≥ 45%;\n6. During screening, DLCO%Pred(corrected for hemoglobin) ≥ 30%;\n7. Stable standard treatment was received before randomization to control ILD and\u002For connective tissue disease;\n\nExclusion Criteria:\n\n1. Diagnosis of Interstitial lung disease other than CTD-ILD;\n2. ILD progresses rapidly within 12 weeks before screening or during screening;\n3. During screening, HRCT showed severe emphysema (the degree of emphysema exceeded that of ILD);\n4. Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) \u002FFVC \\\u003C0.7);\n5. Pulmonary arterial hypertension requiring therapy, as determined by the investigator;\n6. Having diffuse alveolar hemorrhage (DAH) or other pulmonary conditions that may have confounding effects, as well as related signs or symptoms;\n7. Unable to complete the pulmonary function test, or requiring supplementary oxygen supply;\n8. Clinically significant laboratory abnormalities;\n9. QTc interval prolongation on ECG;\n10. Allergy to human or mouse-derived biological products, or history of other drug allergies, and the investigator deems that the patient is not eligible to participate.\n11. Previous treatments received:\n\n    * Previous or planned organ transplantation or bone marrow transplantation;\n    * Plasma exchange or extracorporeal light separation exchange was performed within 6 months before randomization, or a plasma filtration device was used;\n    * Any targeted BLyS or APRIL drug treatment was received within 12 weeks before randomization;\n    * Biologic therapy was received within 12 weeks or within 5 half-lives of the corresponding drug (whichever is longer) before randomization;\n    * B-cell depletion drugs were used within 6 months before randomization;\n    * Non-biological systemic immunosuppressive drugs other than standard treatment were used within 4 weeks before randomization;\n    * Anti-fibrotic drugs were used within 4 weeks before randomization;\n    * Cyclophosphamide treatment was received within 6 months before randomization;\n    * Cytotoxic drugs were used within 6 months before randomization;\n    * Intravenous or intramuscular glucocorticoids were used within 4 weeks before randomization;\n12. Major surgery within 12 weeks prior to screening or planned during the duration of the study；\n13. Received or plan to receive any live vaccine within 28 days prior to randomization;\n14. Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);\n15. has active hepatitis or a history of severe liver disease；\n16. Acute or chronic infection requiring treatment;\n17. suffered from symptomatic herpes zoster within 12 weeks prior to screening;\n18. Active tuberculosis；\n19. HIV infection;\n20. History of malignant tumors；\n21. Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the trial;\n22. History of drug or alcohol abuse or dependence；\n23. Pregnant or lactating women, and those intending to become pregnant during the trial;\n24. Patients considered unsuitable by the investigator to participate in the trial ;",{"count":96,"type":22},260,[26],"Interstitial lung disease (ILD) is a common pulmonary manifestation in chronic tissue diseases (CTD), significantly affecting patient's prognosis.\n\nThe main purpose of this study is to evaluate the efficacy of telitacicept compared with placebo in slowing down the decline in lung volume in patients with interstitial lung disease associated with connective tissue disease (CTD-ILD) on the basis of standard treatment.",[100],"CTD-ILD","2026-04-06",{"date":103,"type":34},"2026-04-09",{"date":58,"type":22},{"date":106,"type":22},"2030-05-31",{"name":40,"class":41},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":88},"100612134","phase-3-a-study-of-telitacicept-in-patients-with-ocular-myasthenia-gravis-omg-100612134","NCT07249632","A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)","A Phase III Trial of Telitacicept in Patients With Ocular Myasthenia Gravis","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form.\n2. Age 12 to 80 years, inclusive, male or female.\n3. Body weight ≥30 kg.\n4. Diagnosis of Myasthenia Gravis (MG) with documented clinical features consistent with the disease.\n5. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Type I.\n6. On a stable standard-of-care (SOC) treatment regimen.\n\nExclusion Criteria:\n\n1. Concomitant autoimmune diseases requiring systemic corticosteroid therapy.\n2. Clinically significant laboratory abnormalities.\n3. Use of other immunosuppressants (not part of the stable SOC) within 1 month prior to randomization.\n4. Presence of an acute or chronic infection requiring treatment.\n5. Current active hepatitis or history of severe liver disease.\n6. Positive for HIV antibodies.\n7. Positive for syphilis antibodies (non-specific or specific).\n8. Poorly controlled diabetes mellitus, defined as HbA1c \\>9.0% or fasting blood glucose ≥11.1 mmol\u002FL.\n9. Subjects with thymoma (classified as ≤ Stage II for benign and ≥ Stage III for malignant according to the Masaoka staging system) .\n10. Presence of uncontrolled chronic degenerative diseases, psychiatric disorders, or neurological diseases other than MG that could interfere with study assessments.\n11. Other diseases causing ptosis, peripheral muscle weakness, or diplopia (e.g., Graves' ophthalmopathy, blepharospasm, progressive external ophthalmoplegia, muscular dystrophy, brainstem or cranial nerve lesions, etc.).\n12. Known allergy to human-derived biological products.","12 Years","80 Years",{"count":118,"type":22},120,[26],"This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible subjects aged 12 to 80 years with a diagnosis of OMG (Myasthenia Gravis Foundation of America \\[MGFA\\] Clinical Classification Type I) will be randomized in a 1:1 ratio to receive either Telitacicept or a matching placebo. Subjects must be on a stable standard-of-care therapy and have an MG Impairment Index (PRO) ocular score of ≥6 at screening and baseline.The dose is age and weight based.The primary objective is to evaluate the efficacy of Telitacicept compared to placebo in treating OMG.The primary efficacy endpoint is the change from baseline in the MGII (PRO) ocular score at Week 24. Secondary endpoints include changes from baseline in other ocular and total scores from MGII, Myasthenia Gravis-Activities of Daily Living (MG-ADL), MG Clinical Absolute Score, and the 15-item Myasthenia Gravis Quality of Life Revised scale (MG-QOL15r). Safety and tolerability will be monitored throughout the study.",[122],"Myasthenia Gravis, Ocular",{"date":103,"type":34},{"date":125,"type":34},"2026-01-13",{"date":127,"type":22},"2027-02-28",{"name":40,"class":41},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":148,"locationsCount":88},"100617217","phase-3-a-study-of-disitamab-vedotin-combined-with-trastuzumab-and-tislelizumab-versus-chemotherapy-combined-with-trastuzumab-with-or-without-pembrolizumab-in-her2-high-expression-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100617217","NCT07315750","A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma With HER2-high Expression","Inclusion Criteria:\n\n* Voluntarily consent to participate in the study and sign the informed consent form\n* Expected survival period \\>12 weeks\n* ECOG Performance Status 0 or 1\n* Histologically confirmed unresectable locally advanced or metastatic --gastric\u002Fgastroesophageal junction adenocarcinoma\n* No prior systemic therapy for locally advanced or metastatic gastric cancer; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant\u002Fadjuvant therapy\n* HER2-high expression\n* At least one assessable lesion according to RECIST v1.1 criteria\n* Adequate organ function\n* Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.\n* Able to understand the study requirements and willing to comply with the study and follow-up procedures\n\nExclusion Criteria:\n\n* Presence of central nervous system (CNS) metastasis and\u002For carcinomatous meningitis\n* Peripheral neuropathy \\> Grade 1\n* Tumor lesions with a tendency to bleed\n* Severe gastrointestinal dysfunction that may affect drug intake, transport, or absorption\n* Bone metastases with a risk of paraplegia\n* Past or current interstitial lung disease, or severely impaired lung function\n* Other malignancies within 5 years prior to randomization, except for those expected to be cured with treatment\n* Pregnant or breastfeeding women",{"count":137,"type":22},555,[26],"The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma with HER2-high Expression.",[141],"Gastric Carcinoma","2026-01-20",{"date":144,"type":34},"2026-01-21",{"date":146,"type":22},"2026-01-01",{"date":38,"type":22},{"name":40,"class":41},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":168},"100601032","phase-1-a-iii-phase-clinical-study-to-evaluate-the-safety-and-efficacy-of-rc278-in-the-treatment-of-solid-tumors-100601032","NCT07105215","A I\u002FII Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors","A Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor","Inclusion Criteria:\n\n1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;\n2. Age between 18 and 75 years (including 18 and 75 years);\n3. ECOG PS score of 0 or 1;\n4. Expected survival ≥12 weeks;\n5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;\n6. Sufficient bone marrow, liver, kidney, and blood clotting function\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or intending to become pregnant subjects.\n2. Subjects with brain metastases.\n3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.\n4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.\n5. Subjects with acute, chronic, or symptomatic infections.\n6. Subjects with uncontrolled cardiovascular diseases.\n7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.\n8. Subjects with a history of cirrhosis (Child-Pugh B or C class).\n9. Subjects with active inflammatory bowel disease.\n10. Subjects with uncontrolled diabetes (HbA1c ≥ 10%).\n11. Subjects who experienced arterial\u002Fvenous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.\n12. Subjects with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.\n13. Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.\n14. Subjects with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.\n15. Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.\n16. Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.\n17. Subjects with poor adherence, who are unlikely to comply with the trial procedures.\n18. Subjects with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the subject unsuitable for the investigational drug, or which may affect the interpretation of the study results, or place the subject at high risk.",{"count":157,"type":22},312,[75,25],"The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and\u002For maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess the efficacy of RC278 at the RP2D dose;",[78],"2025-11-24",{"date":163,"type":34},"2025-11-26",{"date":165,"type":34},"2025-08-11",{"date":106,"type":22},{"name":40,"class":41},39,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":88},"100529775","phase-2-dv-in-combination-with-pertuzumab-with-or-without-toripalimab-neoadjuvant-therapy-with-her2-positive-breast-cancer-100529775","NCT06178159","DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer","A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form;\n2. Ages≥18 years;\n3. Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter \\> 2 cm), cN0- 3, M0;\n4. Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing;\n5. Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic therapy for breast cancer, as assessed by site.\n6. At least one measurable lesion according to RECIST v1.1 criteria;\n7. Cardiac function: New York Heart Association (NYHA) class \\\u003C3; left ventricular ejection fraction ≥55%;\n8. Bone marrow or organ function, the following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial centre, no transfusion of blood, haematopoietic stimulating factors, albumin or blood products within 14 days prior to the test): haemoglobin ≥ 90 g\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002FL; platelets ≥ 100 × 109 \u002FL; serum total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN); Albuminous Transaminase (AST) and Albuminous Transaminase (ALT) ≤ 2.5 × ULN; International Normalised Ratio (INR) and Activated Fractional Thromboplastin Time ≤ 1.5 × ULN; and Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula method;\n9. Subjects of childbearing potential who meet the following criteria:\n\n   1. A serum pregnancy test (minimum sensitivity of 25 mIU\u002FmL or equivalent units of β-human chorionic gonadotropin \\[β-hCG\\]) must be negative within 72 hours prior to the first dose of study intervention. Subjects with false-positive results and confirmed non-pregnancy will be eligible for participation in the study.\n   2. Must agree to contraception for the duration of the study and for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).\n   3. Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of study drug (7 months after the last dose of patulizumab).\n   4. If sexually active and likely to result in pregnancy, use of at least 2 acceptable contraceptive methods, at least 1 of which must be highly effective, must be continued from the time of informed consent for at least 6 months after the last dose of study drug (7 months after the last dose of patulizumab).\n10. Subjects of childbearing potential who meet the following criteria:\n\n    1. Must agree not to donate sperm from the time of signing the informed consent until at least 4 months after the last dose of study drug (7 months after the last dose of patulizumab).\n    2. If sexual intercourse with a person of childbearing potential is likely to result in pregnancy, the use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective, must be continuous, beginning at the time of informed consent and continuing until at least 4 months after the last dose of study drug (7 months after the last dose of patuximab).\n    3. If sex with a pregnant or breastfeeding patient, condom use must be continued from the start of informed consent and continue until at least 4 months after the last dose of study drug (7 months after the last dose of patuximab).\n\n12\\. Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow up procedural arrangements.\n\nExclusion Criteria:\n\n1. With bilateral invasive breast cancer\n2. Previous history of invasive breast cancer\n3. Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery\n4. Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs\n5. Prior anti-HER2 therapy including but not limited to ADC\n6. Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration\n7. Vaccination with live or live attenuated vaccine within 4 weeks prior to the start of study drug administration or planned for the duration of the study;\n8. History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation;\n9. Uncontrolled or significant cardiovascular disease, including (but not limited to): any of the following within 6 months prior to the first dose: e.g., congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (except for lacunar cerebral infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathy (e.g., dilated cardiomyopathy, Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); history of clinically significant prolongation of the QTc period, grade II type II AV block or grade III AV block or QTc interval (F method) \\>470 msec (women) or \\>450 msec (men); atrial fibrillation (EHRA grade ≥2b); uncontrolled hypertension that is judged by the investigator to be unsuitable; and Hypertension, judged by the investigator to be unsuitable for participation in the study;\n10. History of interstitial lung disease requiring treatment or current severe lung disease including, but not limited to, active tuberculosis, interstitial lung disease;\n11. A clear past or present history of a neurological or psychiatric disorder, including epilepsy or dementia;\n12. Persistent grade ≥2 sensory or motor neuropathy;\n13. Active infection requiring systemic therapy; active infection requiring systemic therapy ≤7 days prior to study drug administration, with routine antimicrobial prophylaxis permitted; positive HIV test results; patients with active hepatitis B or C (HBsAg positivity with HBV DNA titres above the upper limit of normal; HCVAb positivity with HCV RNA titres above the upper limit of normal); and persistent coronavirus (COVID-19) infection.\n14. Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of corticosteroids or immunosuppressive drugs, etc.), allowing for related replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency);\n15. Other malignancy within 5 years prior to signing the Informed Consent Form (with the exception of non-melanoma skin cancer, cervical carcinoma in situ, limited prostate cancer, stage I endometrial cancer, or other tumours that have been effectively treated and are considered to have been cured);\n16. Hypersensitivity reactions or delayed hypersensitivity reactions to certain components of vedicilizumab, patulizumab and treprostinil or similar drugs are known;\n17. A concomitant disease that, in the judgement of the investigator, is a serious hazard to the safety of the subject or interferes with the subject's ability to complete the clinical study;",{"count":177,"type":22},40,[25],"The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.",[181],"Breast Cancer",[181,183],"HER2-positive","2025-09-26",{"date":186,"type":34},"2025-10-01",{"date":188,"type":34},"2023-11-28",{"date":190,"type":22},"2026-12",{"name":40,"class":41},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100590088","phase-2-a-phase--study-of-rc108-in-combination-with-furmonertinib-for-the-first-line-treatment-of-egfr-mutated-combined-met-positive-unresectable-locally-advanced-or-recurrent-metastatic-nsclc-100590088","NCT06962865","A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC","A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC","Inclusion Criteria:\n\n1. Voluntarily participate in the study and signed the ICF;\n2. Male or female, aged 18-75 years;\n3. All participants to be enrolled must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced (stage IIIB\u002FIIIC )or recurrent metastatic NSCLC (stage IV ) and not amendable to curative surgery or radiation as assessed by investigator;\n4. For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy;\n5. Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity;\n6. Ability to provide at least 6 sections of tumor tissue specimens for staining and testing；\n7. ECOG PS score 0 or 1；\n8. At least one measurable lesion according to RECIST v1.1 criteria；\n9. Expected survival ≥ 12 weeks;\n10. Adequate bone marrow and organ function；\n11. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose, during which time the female subject is not breastfeeding and the male subject avoids sperm donation.\n\nExclusion Criteria:\n\n1. Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases；\n2. Received ADC or MET inhibitors；\n3. Suffering from refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow pharmaceutical preparations, or previous major bowel resection that may prevent adequate absorption, distribution, metabolism, or excretion of oral medications;\n4. Subjects with uncontrolled tumor-related pain；\n5. Use of an investigational drug or major surgery within 4 weeks before the first dose;\n6. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study;\n7. Subjects with uncontrolled or severe cardiovascular disease;\n8. Presence of clinically uncontrollable third interstitial effusion;\n9. Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc.\n10. Toxicity due to prior antineoplastic therapy has not recovered to National Cancer Institute Commonly Used Criteria Terminology for Generic Adverse Events, Version 5.0, Grade 0-1;\n11. Persistent grade ≥2 sensory or motor neuropathy;\n12. Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis;\n13. Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS);\n14. Active hepatitis B or HCV-positive subjects;\n15. Received systemic corticosteroid therapy with \\>10 mg\u002Fday prednisone or other immunosuppressive medications within 2 weeks before randomization;\n16. Other malignant tumor within 5 years before signed the informed consent form;\n17. Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug;\n18. Poor compliance and unable to complete the study procedures as assessed by investigator;",{"count":21,"type":22},[25],"Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC",[55],"2025-07-13",{"date":205,"type":34},"2025-07-16",{"date":207,"type":34},"2025-06-30",{"date":209,"type":22},"2027-12-31",{"name":40,"class":41},34,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":88},"100588676","phase-3-a-study-of-disitamab-vedotin-combined-with-tislelizumab-and-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-in-her2-low-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100588676","NCT06944496","A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase III, Randomized Trial Comparing RC48 Plus Chemotherapy and Tislelizumab With Tislelizumab Plus Chemotherapy as First-line Treatment in Participants With HER2 Low Advanced Gastric or Gastrioesophageal Junction Adenocarcinoma (RC48-C039)","Inclusion Criteria:\n\n* Voluntarily consent to participate in the study and sign the informed consent form\n* Expected survival period \\>12 weeks\n* ECOG Performance Status 0 or 1\n* Histologically confirmed unresectable locally advanced, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma\n* No prior systemic therapy for locally advanced or metastatic gastric cancer\n* HER2-low expression\n* At least one assessable lesion according to RECIST v1.1 criteria\n* Adequate organ function\n* For female subjects: They should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment. A blood pregnancy test must be negative within 7 days before the study medication is administered, and they must not be breastfeeding\n* For male subjects: They should be surgically sterilized or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment\n* Able to understand the study requirements and willing to comply with the study and follow-up procedures\n\nExclusion Criteria:\n\n* Presence of central nervous system (CNS) metastasis and\u002For carcinomatous meningitis\n* Peripheral neuropathy \\> Grade 1\n* Tumor lesions with a tendency to bleed\n* Uncontrolled diarrhea\n* Bone metastases with a risk of paraplegia\n* Past or current interstitial lung disease, or presence of drug-induced pneumonia, radiation pneumonia, or severely impaired lung function\n* Other malignancies within 5 years before the first dose, except for those expected to be cured with treatment (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)\n* Pregnant or breastfeeding women",{"count":220,"type":22},616,[26],"The purpose of this study is to evaluate the efficacy and safety of \\*\\*Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX\\*\\* as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.",[141],"2025-04-23",{"date":226,"type":34},"2025-04-25",{"date":228,"type":22},"2025-05-15",{"date":230,"type":22},"2030-05-15",{"name":40,"class":41},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":88},"100565466","phase-2-efficacy-and-safety-study-of-disitamab-vedotin--rc148-vs-albumin-paclitaxone--toripalimab-in-hr-her2-low-breast-cancer-100565466","NCT06642545","Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-\u002FHER2-low Breast Cancer","A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Voluntarily agree to participate in the study and sign the informed consent form\n* Stage III unresectable locally advanced or Stage IV metastatic breast cancer.\n* Subjects must be willing and able to provide a tumor tissue block and\u002For unstained pathology slides, with priority given to the most recent metastatic lesions that have not previously been subjected to radiotherapy. If this is not feasible or available, then a tumor tissue block (or fresh tissue sections) obtained from locally recurrent lesions should be provided. Freshly obtained tissue is preferred over archived tissue. The provided tissue will be used for biomarker testing and must be suitable for analysis of HER2 expression and PD-L1 expression\n* Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory\n* Invasive tumor tissue is negative for hormone receptors (HR), defined as immunohistochemistry (IHC) testing showing that the proportion of cells with positive nuclear staining for both ER and PgR in invasive cancer is less than 1%. For patients with weakly positive ER\u002FPgR (1% to 10% of tumor cell nuclei positive), those who are not suitable for endocrine therapy after thorough evaluation by the investigator, and with approval from the sponsor after communication, may be included in this study\n* For HR-negative, HER2-low expressing unresectable locally advanced or metastatic breast cancer: locally recurrent and unresectable or previously untreated metastatic breast cancer; or those who have completed curative treatment (excluding radiotherapy) (e.g., the date of surgery for the primary breast tumor or the last date of adjuvant therapy administration, whichever is later), with an interval of ≥6 months from the first documented local or distant disease recurrence. For subjects who received taxane drugs during the (neo)adjuvant therapy phase, there must be an interval of ≥12 months from the last taxane administration\n* ECOG performance status of 0 or 1\n* According to the RECIST v1.1 criteria, there must be at least one measurable lesion (for lesions that have previously been irradiated, if the lesion can be measured according to the RECIST v1.1 criteria and there is evidence of significant progression after radiotherapy, the lesion can be considered a target lesion)\n* Expected survival of at least 12 weeks\n* Hematologic and organ function criteria to be met within 7 days prior to the first dose of study medication (with normal values based on the clinical trial center's standards, and no blood transfusions, hematopoietic growth factors, albumin, or blood products within 14 days prior to the test):\n\nHemoglobin ≥ 90 g\u002FL Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL Platelet count ≥ 100 × 10\\^9\u002FL Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN (for subjects with total bilirubin \\> 1.5 × ULN). Total bilirubin ≤ 3 × ULN (for subjects with Gilbert's disease) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN (if liver metastases are present) International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 40 mL\u002Fmin, or serum creatinine ≤ 1.5 × ULN Urine routine test shows urine protein \\\u003C 2+; if urine protein ≥ 2+, the 24-hour urine protein quantification result must be \\\u003C 1 g.\n\n* Female subjects of childbearing potential who meet the following conditions:\n\nA serum pregnancy test (with a minimum sensitivity of 25 mIU\u002FmL or equivalent units of β-human chorionic gonadotropin \\[β-hCG\\]) must be negative within 7 days prior to the first dose of study intervention. Subjects with a false-positive result that is confirmed not to be pregnant are eligible to participate in the study.\n\nMust agree to use contraception during the study and for at least 6 months after the last dose of study medication. No breastfeeding or egg donation within 6 months.\n\nIf sexual activity could lead to pregnancy, they must use at least one acceptable form of contraception from the time of informed consent until at least 6 months after the last dose of study medication.\n\n* Male subjects of childbearing potential who meet the following conditions:\n\nMust agree to abstain from donating sperm from the start of the study until at least 6 months after the last dose of study medication.\n\nIf having sexual intercourse with a person of childbearing potential that could lead to pregnancy, must consistently use at least one acceptable form of contraception throughout the study and for at least 6 months after the last dose of study medication.\n\nIf having sexual intercourse with a pregnant or breastfeeding partner, must use condoms from the time of informed consent until at least 6 months after the last dose of study medication.\n\n* Capable of understanding the trial requirements and willing and able to comply with the trial and follow-up procedures.\n\nExclusion Criteria:\n\n* Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).\n* Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the locally advanced or metastatic stage (except if the last administration was ≥12 months prior to recurrence or progression, using \\[neo\\]adjuvant anti PD-(L)1).\n* Excluding subjects with brain metastases or leptomeningeal metastases. Subjects with treated brain metastases (surgery and\u002For radiotherapy) are eligible for inclusion if they meet the following criteria:\n\nSubjects who have received treatment for brain metastases may be considered for participation in this study if they have not experienced disease progression as determined by imaging studies within 4 weeks prior to the first dose of study treatment.\n\nThey must have discontinued the use of corticosteroids or anticonvulsant therapy at least 14 days before the first dose of study\n\n* Use of investigational drugs or undergoing major surgery within 4 weeks prior to the first dose of study medication\n* Received or plan to receive live vaccines or attenuated live vaccines within 4 weeks prior to the first dose of study medication or during the study period\n* History of allogeneic hematopoietic stem cell transplantation or organ transplantation\n* Uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to):\n\nWithin 6 months prior to the first dose of study medication, any of the following occurred: congestive heart failure (NYHA Class III or IV), myocardial infarction, or cerebral infarction (except for lacunar infarction), pulmonary embolism, unstable angina, or the presence of arrhythmias requiring treatment at screening; Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's formula) \\> 470 msec (females) or \\> 450 msec (males); Atrial fibrillation (EHRA classification ≥ class 2b); Uncontrolled hypertension, as judged by the investigator to be unsuitable for participation in the study\n\n* Presence of clinically uncontrollable third space fluid accumulation, such as large amounts of pleural effusion, pericardial effusion, or ascites that are associated with clinical symptoms or require symptomatic treatment.\n* History of interstitial lung disease that requires treatment or current severe pulmonary disease, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.\n* A clear history of neurological or psychiatric disorders, either past or present, including epilepsy or dementia, etc.\n* Toxicities from previous anti-cancer treatments have not yet recovered to grade 0-1 of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), except for alopecia, hyperpigmentation, or other conditions that the investigator deems do not increase the risk to the subject from treatment.\n* Persistent grade ≥2 sensory or motor neuropathy.\n* Active infections that require systemic treatment:\n\nActive infections requiring systemic treatment within 7 days prior to the first dose, routine antimicrobial prophylaxis is allowed; Positive HIV test results; Patients with active hepatitis B or C (HBsAg positive with detectable HBV DNA levels above the upper limit of normal; HCVAb positive with detectable HCV RNA levels above the upper limit of normal).\n\n* Having active autoimmune diseases within the past 2 years that require systemic treatment (such as corticosteroids or immunosuppressive drugs), except for replacement therapies (such as thyroid hormone, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency).\n* Having other malignant tumors within 5 years prior to signing the informed consent form (except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, stage I endometrial cancer, or other tumors that are considered cured).\n* Known hypersensitivity or delayed-type allergic reactions to certain components of Disitamab Vedotin, Toripalimab, RC148, or albumin-bound paclitaxone, or similar drugs.\n* According to the investigator's judgment, there are serious concomitant diseases that could endanger the subject's safety or affect the subject's ability to complete the clinical study.",{"count":177,"type":22},[25],"Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer",[181],"2025-02-14",{"date":245,"type":34},"2025-02-17",{"date":247,"type":34},"2025-02-10",{"date":249,"type":22},"2027-10-01",{"name":40,"class":41},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100519042","phase-1-a-study-of-rc118-plus-toripalimab--rc148-in-patients-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100519042","NCT06038396","A Study of RC118 Plus Toripalimab \u002F RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab \u002F RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","Inclusion Criteria:\n\n1. Be able to participate in the study voluntarily and willing to provide written informed consent.\n2. male or female 18 ≤ age ≤ 75 years old.\n3. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n4. The expected survival ≥12 weeks.\n5. Enrollment of subjects with locally advanced or metastatic gastric adenocarcinoma\u002Fadenocarcinoma of the gastroesophageal junction who have a histologically confirmed diagnosis and have failed standard therapy.\n6. Subjects who received ≤2 prior systemic therapies.\n7. Subjects agree to provide tumor tissue specimens for Claudin 18.2 and PD-L1 expression levels during the screening period. Samples should have moderate to high expression of Claudin 18.2 by membrane staining.\n8. According to the RECIST v1.1, there is at least one measurable target lesion.\n9. Sufficient heart, bone marrow, liver and kidney functions.\n10. Fertile male or female subjects must agree to take effective contraceptive measures during the study period and for 6 months after the end of the last dose, such as double-barrier contraceptive methods(eg. condoms), oral or injectable contraceptives, intrauterine.\n\nExclusion Criteria:\n\n1. Pregnant women, breastfeeding women or women with a positive blood pregnancy test result during the screening period (non-fertile women do not need to undergo a pregnancy test, such as women with a previous hysterectomy and\u002For bilateral oophorectomy or amenorrhea ≥12 months).\n2. Subjects with active hepatitis B (HBsAg positivity and HBV DNA titre higher than the normal upper limit), active hepatitis C (HCVAb positivity and HCV RNA titre higher than the normal upper limit), and positive human immunodeficiency virus antibody (HIV-Ab) results during the screening period.\n3. Subjects with a history of other acquired or congenital immunodeficiency diseases, or who have undergone organ or bone marrow transplantation.\n4. Subjects who have previously received monoclonal antibody, double antibody targeting drugs, ADC, CAR-T and other therapeutic drugs targeting Claudin 18.2 or other ADCs with MMAE payload; or have participated in clinical trials and received investigational drugs within 4 weeks before the first dose.\n5. Have vaccinated within 4 weeks prior to the first dose or plan to receive any live vaccine during the study.\n6. Subjects are atallergic to the ingredients or excipients of the experimental drug.\n7. Subjects who have received anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, or targeted therapy) within 4 weeks or less than 5 half-lives of the experimental drug prior to the start of the first dose; or who have received anti-tumor therapy with traditional Chinese medicine or immunomodulators within 2 weeks prior to the start of the first dose.\n8. The toxicity of previous anti-tumor therapy has not returned to the level 0 or 1 as defined by NCI-CTCAE v5.0 (except for alopecia, pigmentation and other long-term toxicity ≤2 that cannot be recovered which was defined by investigators).\n9. The clinical symptoms of pleural effusion, abdominal effusion, or pericardial effusion that requires drainage.\n10. Active infection within 2 weeks prior to the first dose that requires systemic anti-inflammatory therapy.\n11. Complicating other diseases that seriously endanger the safety of the subjects or affect the completion of the study, such as peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure and uncontrolled diabetes (Fasting blood glucose \\> 8.5 mmol\u002FL, HbA1C ≥7.5%).\n12. The tumor lesion has a bleeding tendency or has received blood transfusion treatment within 4 weeks prior to the first dose.\n13. During the screening period, QTc interval \\>450 ms(male), QTc interval \\>470ms(female); previous family or personal history of long\u002Fshort QT interval syndrome; A history of ventricular arrhythmia deemed clinically significant by the investigator, or currently receiving antiarrhythmic medication, or implantation of arrhythmia defibrillation device.\n14. Previous myocardial infarction (within 6 months prior to the first dose), severe or unstable angina, coronary or peripheral artery bypass grafting, heart failure grade 3\\~4 defined by New York Heart Association (NYHA) and uncontrolled hypertension.\n15. Experienced an arterial\u002Fvenous thromboembolic event within 6 months prior to the study.\n16. Active autoimmune disease that requires systemic treatment within 2 years prior to the study. Patients with vitiligo, psoriasis, alopecia or Grave's disease that not requires systemic treatment, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes only requires insulin replacement therapy may be included in the study.\n17. Subjects with brain metastases and\u002For carcinomatous meningitis who have previously received related treatment may be considered for inclusion if their disease has been stable for at least 3 months, no imaging evidence of disease progression has been observed within 4 weeks prior to the first dose, all neurological symptoms have returned to baseline, and radiation, surgery, or steroid therapy has been discontinued at least 28 days prior to the first dose; cancerous meningitis should be excluded regardless of whether it is clinically stable.\n18. Other malignant tumor within 5 years prior to the signature of informed consent.\n19. Major surgery or interventional therapy was performed within 4 weeks prior to the first dose and did not fully recovered (except tumor biopsy and puncture).\n20. For Phase II subjects:\n\n    * Received an immune checkpoint inhibitor (anti-PD-1\u002FPD-L1\u002FCTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to the first treatment with the test drug;\n    * Prior concurrent receipt of antitumor agents targeting VEGF\u002FVEGFR and PD-1\u002FPD-L1;\n    * Experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of study drug;\n    * Currently receiving anticoagulant medications (except for subjects on prophylactic doses of heparin).\n21. A history of uncontrollable mental illness or subjects currently experiencing such conditions.\n22. Subjects with poor compliance who are expected to be unable to complete the study.",{"count":259,"type":22},48,[75,25],"This is an open, multi-center, dose escalation and expansion phase I\u002FII study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer\u002FGastro-esophageal junction cancer.",[263],"Advanced Solid Tumor","2025-01-26",{"date":266,"type":34},"2025-01-29",{"date":268,"type":34},"2023-08-03",{"date":270,"type":22},"2026-08-31",{"name":40,"class":41},18,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100455077","phase-1-a-study-of-rc118-in-patients-with-locally-advanced-unresectable-or-metastatic-malignant-solid-tumors-100455077","NCT05205850","A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","An Open, Multi-center Phase I\u002FIIa Clinical Study of RC118 for Injection in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors with Positive Expression of Claudin 18.2","Inclusion Criteria:\n\n1. Volunteer to participate in this study and sign written informed consent\n2. 18 years old ≤ age ≤ 75 years old, no gender limit\n3. ECOG physical status score is 0 or 1 point\n4. The expected survival time exceeds 12 weeks\n5. Standard treatment is ineffective (disease progression or no remission after treatment), patients who cannot tolerate standard treatment, locally advanced unresectable or metastatic malignant solid tumors\n6. The subject agrees to provide freshly collected tumor tissue specimens or collected and preserved tumor tissue specimens within 2 years during the screening period for CLDN 18.2 testing, and must meet the following criteria： A.Phase I dose escalation stage\u002Fdose confirmation stage: patients with gastric cancer, esophageal cancer, gastroesophageal junction cancer, pancreatic cancer, ovarian cancer, and cholangiocarcinoma with positive Claudin 18.2 expression (membrane staining is observed in any tumor cells); B.Phase IIa Dose Expansion phase: (positive membrane staining observed in any tumour cell) patients with gastric\u002Fgastro-oesophageal adenocarcinoma, pancreatic cancer; C. Phase IIa dose-optimisation phase: patients with gastric\u002Fgastro-oesophageal adenocarcinoma with Claudin 18.2-positive (positive membrane staining observed in any tumour cell)\n7. According to the RECIST v1.1 standard, based on imaging examination (CT\u002FMRI), there is at least one measurable or evaluable target lesion\n8. Sufficient bone marrow, liver, and kidney functions (subject to the normal value of the clinical trial center): absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, platelet ≥ 100×109\u002FL, hemoglobin ≥ 90 g\u002F L, serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT, AST or ALP ≤ 3 times ULN without liver metastasis; ALT, AST or ALP ≤ 5 times ULN with liver metastasis, serum creatinine ≤ 1.5 Times ULN, International Normalized Ratio (INR) ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN\n9. Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding, or women whose blood pregnancy test results are positive during the screening period (female subjects who are infertile do not need to undergo a pregnancy test, such as hysterectomy and\u002For bilateral ovaries in the past Women with resection or amenorrhea ≥12 months)\n2. Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab) during the screening period\n3. Subjects with a prior history of other acquired, congenital immunodeficiency diseases; subjects who are preparing for or have previously undergone organ or bone marrow transplantation;\n4. Those who have previously received targeted therapy drugs for Claudin 18.2; or participated in clinical trials of other drugs within 4 weeks before the first administration and received trial drugs\n5. Have vaccinated within 4 weeks before the first dose or plan to vaccinate any vaccine during the study period\n6. Allergic to known research drug ingredients or excipients\n7. Combined use of vitamin K antagonist anticoagulant drugs; combined use of therapeutic doses of heparin (subjects using preventive doses of heparin can be included in the study)\n8. Received anti-tumor therapy (surgery, chemotherapy, radiotherapy, biological therapy) within 4 weeks before the first administration, and received palliative radiotherapy for bone metastases within 2 weeks\n9. The toxicity of previous anti-tumor treatments has not returned to the level 0 or 1 of NCI-CTCAE v5.0 (except for hair loss)\n10. There are clinical symptoms of pleural fluid, ascites, and pericardial effusions require drainage (patients who do not require drainage or whose drainage is discontinued and who do not have a significant increase in effusion within 5 days may be included in the study)\n11. According to the judgment of the investigator, an active infection with clinical significance\n12. Combined with other diseases that seriously endanger the safety of the subject or affect the completion of the test, such as gastrointestinal bleeding (within 4 weeks before the first dose), peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, lung Fibrosis, kidney failure, and uncontrolled diabetes\n13. QTc interval during the screening period\\>480 ms (based on the average of 3 screening electrocardiograms); previous family or personal history of long\u002Fshort QT interval syndrome; ventricular arrhythmia deemed clinically significant by the investigator Medical history, or currently receiving antiarrhythmic drug treatment, or implantation of arrhythmia defibrillation device\n14. Past myocardial infarction (within 6 months before the first administration), severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade 3\\~4 heart failure, no Controlled hypertension\n15. People who have had alcohol dependence or drug abuse in the past\n16. Those who have received systemic steroid therapy for a long period of time (Note: Short-term use (≤ 7 days) and withdrawal\\> 2 weeks can be selected)\n17. Patients who have previously or currently suffered from uncontrolled primary or metastatic brain tumors, and the investigator believes that patients who have been stabilized or whose local treatment has ended may be considered for inclusion in the group\n18. Past or current peripheral neuropathy ≥ Grade 2\n19. Past or current mental illness that is difficult to control\n20. Subjects who have poor compliance and are not expected to cooperate to complete the test procedure\n21. Other subjects deemed unsuitable to participate in clinical research by the investigator\n22. Serious arterial\u002Fvenous thrombosis or cardiovascular accident within 6 months prior to dose administration, such pulmonary embolism, cerebral infarction, cerebral hemorrhage, except for asymptomatic lacunar infarction that does not require clinical intervention;",{"count":281,"type":22},135,[75,25],"In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。",[263],"2025-01-22",{"date":287,"type":34},"2025-01-27",{"date":289,"type":34},"2022-03-03",{"date":291,"type":22},"2025-12-01",{"name":40,"class":41},2,{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100517324","phase-1-a-study-of-rc148-as-a-single-agent-and-combination-therapy-in-patients-with-locally-advanced-unresectable-or-metastatic-malignant-solid-tumors-100517324","NCT06016062","A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","A Multi-center Phase I\u002FII Trial to Evaluate the Efficacy and Safety of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors","Inclusion Criteria:\n\n1. Be able to participate in the study voluntarily and willing to provide written informed consent.\n2. male or female ≥18 years (phase Ⅰ), 18 to 75 years old (Including 18 and 75 years, phase Ⅱ).\n3. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n4. Projected life expectancy of at least 12 weeks.\n5. At least one measurable target lesion based on imaging according to RECIST v1.1 criteria (For patients who have received prior radiotherapy, radiotherapy-treated lesions may be considered as target lesions if the lesion is measurable according to RECIST v1.1 criteria and there is evidence of significant progression after radiotherapy.);\n6. Requirements for inclusion of subjects at different stages:\n\n   Phase I (RC148 monotherapy): Patients with locally advanced unresectable or metastatic malignant solid tumors whose disease has progressed with standard therapy, or who are unable to tolerate standard therapy, or in whom the subject refuses standard therapy;\n\n   Phase II (Combination Therapies):\n\n   Cohort 1 (non-small cell lung cancer): Patients with locally advanced unresectable or metastatic malignant solid tumors with disease progression on standard therapy, or intolerance of standard therapy, or refusal of standard therapy.\n\n   Cohort 2 (HER2-expressing cervical cancer): Subjects with advanced non-small cell lung cancer diagnosed by histological or cytological examination, locally advanced or metastatic, with AGA- confirmed by prior genetic testing, who have received a PD-1\u002FPD-L1 inhibitor and platinum-based chemotherapy as a first or second-line advanced treatment, and who have not received docetaxel chemotherapy.\n\n   Cohort 3 (HER2 expressing gastric cancer): Histologically and\u002For cytologically confirmed locally advanced or metastatic gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) with HER2 expression (IHC ≥1+). Subjects who have progressed or are intolerant to standard first-line therapy only (PD-1\u002FPD-L1 inhibitor + platinum-containing chemotherapy ± trastuzumab, and not including paclitaxel). Disease progression during neoadjuvant therapy and within 6 months of the end of adjuvant therapy will also be considered a failure of first-line therapy.\n\n   Cohort 4 (MSLN-expressing lung adenocarcinoma): Histologically or cytologically confirmed lung adenocarcinoma without other pathologic components; driver gene negative, MSLN-expressing (IHC ≥1+) advanced lung adenocarcinoma subjects who have received PD-1\u002FPD-L1 inhibitor and platinum-based chemotherapy (combination or sequential) and have not received paclitaxel-based chemotherapy.\n\n   Cohort 5 (platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer): pathologic type needs to be high-grade serous ovarian cancer; Subjects who have progressed on prior 1-4 lines of antitumor therapies; Definition of platinum-resistance: 1) Patients who have received 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR), and then progressed between \\>3 months and ≤6 months after the date of the last platinum; 2) Patients who have received 2 or 3 lines of platinum-based therapies must have received at least 4 cycles of platinum and have progressed on or within 6 months after the last dose of platinum.\n\n   Cohort 6 (platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer): Pathological type needs to be high-grade serous EOC; Subjects who have received 1-4 lines of prior antitumor therapies were included.\n\n   Cohort 7 (MSLN-expressing cervical cancer): Subjects with recurrent or metastatic cervical cancer expressing mesothelin (MSLN) (IHC ≥1+) that is histologically confirmed, ineligible for surgery or radiotherapy, and has progressed after at least 1L of platinum-based chemotherapy.\n7. Participants agree to provide pre-treatment archived\u002Fbiopsied tumor samples for biomarker-related testing such as retrospective programmed cell death protein 1 (PD-L1) expression levels. Biopsies will be considered at screening only if archived samples are not available. Fresh tumor biopsies will not be considered if significant risk procedures are required per the discretion of the Investigator.\n8. Adequate bone marrow, liver, and renal function defined as:\n\n   No platelet or red blood cell transfusion within 14 days prior to performing routine blood tests, no correction with thrombopoietin (TPO), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or interleukin-11 (IL-11), absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, and Hemoglobin ≥ 90g\u002FL.\n\n   Serum total bilirubin ≤1.5 × upper limit of normal (ULN), ALT, AST ≤2.5 × ULN (≤5 × ULN in case of known liver metastases), albumin ≥30 g\u002FL International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n\n   Serum creatinine ≤ 1.5 x ULN. Urinalysis results for urinary protein \\\u003C++.\n9. For subjects in Cohort 1 (Non-Small Cell Lung Cancer) and Cohort 4 (Lung Adenocarcinoma) of the Phase II Combined Protocol, pulse oximetry (O2 saturation) measured under unoxygenated conditions was required to be \\>92%.\n10. Cardiac function: left ventricular ejection fraction ≥50%.\n11. Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine contraceptive device.\n\nExclusion Criteria:\n\n1. Pregnant or lactating.\n2. Cohort 1 in Phase II, patients with histologically or cytologically confirmed non-small cell lung cancer, other than squamous lung cancer and lung adenocarcinoma, (including subjects with squamous or adenocarcinoma in combination with other pathologic types of non-small cell lung cancer;) prior treatment with docetaxel, or an antitumor agent that targets VEGF\u002FVEGFR; and treatment with at least 2 cycles of an immune checkpoint inhibitor, with a best response of PD, or best response of CR\u002FPR\u002FSD with disease progression within 6 months of first dose.\n3. Cohorts 4-7 in Phase II, patients with ocular corneal conditions at screening such as congenital corneal dystrophy, meibomian gland dysfunction (MGD), viral keratitis (dendritic, map-like, corneal stromal keratitis), uveitis, corneal endothelial decompensation, glaucoma, iridocorneal endothelial syndrome (ICE).\n4. Subjects with active hepatitis B or C; human immunodeficiency virus (HIV)-positive subjects.\n5. Those who have received a live vaccine within 28 days prior to the first RC148 administration or who plan to receive any live vaccine during the study period.\n6. Participant with a history of other acquired\u002Fcongenital immunodeficiency diseases or organ transplantation.\n7. Active autoimmune disease requiring systemic therapy, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, or rheumatoid arthritis, within the past 2 years; however, alternative therapies are not considered systemic therapies and are permitted for use and enrollment.\n8. Subject has received an immune checkpoint inhibitor (anti-PD-1\u002FPD-L1\u002FCTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to initiation of treatment with the study drug or has experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of the study drug.\n9. Subjects who have participated in a clinical trial of another drug and received the test drug within 4 weeks prior to the first dose of RC148.\n10. Prior concomitant treatment with antitumor agents targeting VEGF\u002FVEGFR and PD-1\u002FPD-L1 (except for subjects with cervical cancer). For cohorts 2-3 in Part 2, subjects with prior antibody-drug conjugates treatment. For cohorts 4-7 in Part 2, subjects with prior antibody-drug conjugates and MSLN-targeting drugs.\n11. Known hypersensitivity or delayed hypersensitivity to certain components of the study drug or to similar drugs.\n12. Participant who are under the treatment of anticoagulant drugs. Participants using prophylactic doses of heparin are eligible in the study.\n13. Subject received last systemic antitumor therapy, including surgery, chemotherapy, radiotherapy, and biologic therapy within 4 weeks prior to the first study drug administration; received small molecule tyrosine kinase inhibitor therapy or immunotherapy within 2 weeks prior to the first drug administration; or received herbal therapy for antitumor indications within 1 week prior to the first drug administration or received bone\u002Fother solitary metastases within 2 weeks prior to the first study drug administration Palliative radiotherapy.\n14. Previous adverse reactions resulting from previous anti-tumour therapies, which have not returned to Grade 1 according to NCI-CTCAE v5.0 at screening.\n15. Presence of grade ≥2 sensory or motor neuropathy.\n16. Presence of third interstitial fluid with clinical symptoms or requiring intervention.\n17. Active infection of clinical significance judged by the investigator.\n18. Active gastrointestinal bleeding, history of hemoptysis, peptic ulcer, or a hemorrhagic event with NCI CTCAE (V5.0) ≥ grade 2 within 4 weeks prior to screening; or the presence of severe esophagogastric varices, nosebleeds; and in the case of subjects with gastric cancer, a tumor lesion with a tendency to bleed.\n19. Presence of systemic diseases that, in the judgment of the investigator, are not under stable control, including diabetes mellitus, hypertension, cirrhosis of the liver, etc.\n20. Those with previous and current clinical manifestations or high risk factors for interstitial lung disease (ILD), drug-associated pneumonia, radiation pneumonitis, severely impaired lung function, or suspected interstitial lung disease.\n21. Clinically relevant pyelonephrosis that cannot be reduced by ureteral stenting or percutaneous drainage.\n22. History of gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction, inflammatory bowel disease, or bowel resection within the past 6 months.\n23. Screening QTc interval \\>450 ms (males), QTc interval \\>470 ms (females); previous family or personal history of long\u002Fshort QT interval syndrome; history of ventricular arrhythmia considered clinically significant by the investigator or currently receiving antiarrhythmic medications or implantation of an arrhythmia defibrillation device.\n24. Experienced an arterial\u002Fvenous thromboembolic event such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, cerebral infarction, or experienced a history of hypertensive crisis or hypertensive encephalopathy within 6 months prior to initiation of study treatment.\n25. History of myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass graft or vascular disease, New York Heart Association (NYHA) grade ≥3 heart failure within 6 months prior to screening; history of fulminant, acute, chronic relapsing, or persistent myocarditis, pericarditis, or epicarditis from any cause within 1 year prior to screening.\n26. Subjects on systemic therapy with corticosteroids (daily prednisone ≥10 mg\u002Fday or equivalent dose of drug) or other immunosuppressive medications within 2 weeks of first study administration.\n27. Subjects with the presence of brain metastases who have been previously treated for brain metastases may be considered for enrollment (exclusion of brain metastases from gastric cancer): provided that the disease is stable, no disease progression has occurred as determined by imaging within 4 weeks prior to dosing, and all neurological symptoms have returned to baseline levels, and that the use of radiation, surgical, or steroid therapy has been discontinued for at least 28 days prior to the first dose of the drug; in the case of carcinomatous meningeal metastases, regardless of their clinical stabilization of symptoms, should be excluded.\n28. Major surgery or intervention with incomplete recovery (except tumor biopsy or puncture) within 4 weeks prior to the first dose of study drug; or gross needle aspiration biopsy or other minor surgery, excluding placement of vascular infusion devices, within 7 days prior to initiation of study drug therapy.\n29. Screening imaging showing tumor invasion of large blood vessels or imaging evidence of tumor invasion of vital organs or risk of developing a fistula; or imaging evidence of tumor encircling a large blood vessel or entry into the study causing a risk of hemorrhage.\n30. Other malignancies were present within 5 years before the initiation of study administration, except for malignancies that would be expected to be cured with treatment.\n31. Previous or current uncontrollable mental illness.\n32. Subjects with poor compliance who were not expected to cooperate in completing trial procedures.\n33. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition that makes the subject unsuitable for the use of the investigational drug, or that would interfere with the interpretation of the results of the study, or that would place the subject at high risk.",{"count":302,"type":22},221,[75,25],"The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.",[306],"Solid Tumor","2025-01-21",{"date":309,"type":34},"2025-01-23",{"date":311,"type":34},"2023-09-14",{"date":313,"type":22},"2025-12-31",{"name":40,"class":41},31,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"100491542","phase-2-a-study-of-telitacicept-in-lupus-nephritis-100491542","NCT05680480","A Study of Telitacicept in Lupus Nephritis","A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis","Main Inclusion Criteria:\n\n1. Males or females aged 18-75 years of age, inclusive.\n2. Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).\n3. Active, biopsy-proven proliferative lupus nephritis Class III or IV with\u002Fwithout the presence of Class V, or pure Class V according to the 2003 ISN\u002FRPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility.\n4. Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and\u002For a positive anti-dsDNA serum antibody based on the study\\'s central laboratory results.\n5. Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.\n6. Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when both HDCS and MMF have been started.\n7. Able to understand the requirements of the study and provide written informed consent.\n\nMain Exclusion Criteria:\n\n1. Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).\n2. History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.\n3. Received any of the following therapies:\n\n   1. Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;\n   2. Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;\n   3. Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;\n   4. Received plasma separation or plasma exchange during the 6 weeks prior to screening;\n   5. Subjects who required dialysis within 1 year prior to screening.\n   6. Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.\n   7. Received BCG Vaccine within 1 year prior to screening.\n4. History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1).\n5. History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fmarrow transplant or are due to receive transplantation.\n6. Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.\n7. Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.\n8. History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).\n9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.\n10. History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.\n11. Have acute or chronic infection requiring treatment.\n12. HIV positive.\n13. Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll.\n14. Hepatitis C antibody positive.\n15. History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.\n16. eGFR\\<30 mL\u002Fmin\u002F1.73 m2 using CKD-EPI.\n17. Renal biopsy showed 50% glomerulosclerosis.\n18. Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables.\n19. Subjects who in the opinion of the investigator are not suitable to participate.",{"count":118,"type":22},[25],"The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.",[327],"Lupus Nephritis",[329,330,331,332],"lupus","nephritis","Telitacicept","RC 18","2024-09-19",{"date":335,"type":34},"2024-09-23",{"date":337,"type":34},"2023-04-17",{"date":339,"type":22},"2026-01",{"name":40,"class":41},45,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":349,"sex":17,"minAge":18,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":365},"100558349","phase-1-a-single-dose-study-to-investigate-the-pharmacokinetics-pk-of-telitacicept-pre-filled-injection-and-freeze-dried-powder-injection-in-chinese-healthy-subjects-100558349","NCT06549959","A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects","An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the Pharmacokinetics of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects","Inclusion Criteria:\n\n1. 18-50 years old at the time of signing the informed consent form，gender is unlimited；\n2. Male Weight 55-70 kg, female Weight 50-65 kg, and BMI ranging from 18 to 28 kg\u002Fm2 (including critical values);\n3. Physical examination, vital signs, chest radiographs, ECG, epidemiologic tests, routine blood tests, blood biochemistry, lipids, urinalysis, and coagulation are normal，or abnormal by the investigator as having no clinical significance；\n4. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete all trial procedures according to the trial requirements.\n\nExclusion Criteria:\n\n1. Site staff and family members directly involved in the trial; or sponsor staff and family members directly involved in the implementation of the trial;\n2. History of any of any nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood and lymphatic system, skeletal muscle system, immune system, metabolic system disease, or other diseases that are not suitable for clinical trials (such as mental history, malignant tumors, etc.);\n3. History of lymphoproliferative disease (e.g., EB virus associated lymphoproliferative disease), lymphoma, leukemia, myeloproliferative disease, multiple myeloma, or signs and symptoms suggestive of lymphoproliferative disease;\n4. History of abnormal bleeding or coagulation disorders (such as prone to bruising, gingival bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, heavy menstruation leading to anemia within 1 year, postpartum hemorrhage, vitamin K deficiency, hemorrhagic disease caused by acquired coagulation factor antibodies, bleeding after trauma or surgery, etc.) , or abnormal laboratory coagulation parameters, or an inherited tendency to bleed or have coagulation dysfunction, or have a history of blood clots or bleeding, or require long-term use of anticoagulants or antiplatelet aggregation drugs;\n5. During screening, 12-lead ECG showing QTcF≥450 ms in male or QTcF≥470 ms in female, or the presence of degree II\u002FIII atrioventricular block, or other clinically significant ECG abnormalities are judged by investigators not inappropriate;\n6. The first-degree relatives of the subject had inherited immunodeficiency;\n7. Current allergic disease, or history of allergy to therapeutic or diagnostic protein products ,allergy to alcohol(alcohol is used to sterilize injection sites), or allergy to two or more drugs and\u002For non-drug factors;\n8. Surgery within 6 months prior to screening, or planned surgery during the trial, or within 2 weeks of the end of the trial(including cosmetic surgery, dental surgery, oral surgery, etc.);\n9. Participation in a clinical trial of another drug within 3 months prior to screening;\n10. Use of drugs that inhibit or induce hepatic metabolism within 4 weeks prior to randomization or need for use during the trial(e.g., inducers--barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors--SSRI antidepressants, cimetidine, Diltiazem macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);\n11. Current use of any prescription or over-the-counter (herbal, vitamins, or healthcare products). Current use is defined as use within 14 days or PK equivalent of 5 half-lives prior to randomization, whichever is longer;\n12. History of Bleeding or donated more than 100ml blood 3 months before screening period, or plan to denote blood within 1 month after the trial;\n13. Positive breath test results for alcohol or alcoholism in the 6 months prior to the screening period(≥14 units of alcohol per week: one standard unit contains 14g of alcohol, equals to 360ml of beer, 45ml of 40% liquor or 150ml of wine), or unable to stop drinking during the trial;\n14. More than 5 cigarettes per day within 6 months prior to screening , or unable to quit smoking during the trial;\n15. Consume excessive caffeine-containing beverages, foods that may affect drug metabolism within four weeks prior to screening: coffee (≥1100 mL per day), tea (≥2200 mL per day), cola (≥2200 mL per day), energy drinks (≥1100 mL per day), chocolate (≥510 g per day);\n16. History of drug abuse, drug dependence, or drug use within 5 years prior to screening；\n17. Subject may use weight-loss medications, or excessive dieting, or overeating during the trial;\n18. Tattoos, scarring, or other conditions in the planned injection site area (front of thigh) that may interfere with the evaluation of the injection site;\n19. COVID-19 vaccine within 2 weeks prior to randomization，or live vaccine within 30 days prior to randomization， or live vaccine required during the trial;\n20. Positive test for Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, tuberculin test (IGRAs);\n21. History of any clinically significant infections within 6 months prior to screening (e. g., requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections);\n22. History of symptomatic herpes zoster or herpes simplex, more than one episode of localized herpes zoster, or disseminated herpes zoster (single episode) within 12 weeks prior to screening；\n23. Female subjects with a positive pregnancy test during screening period，or lactating female ; subjects and their partners do not agree to take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) throughout the trial and within 4 months after injection of the Investigational drug;\n24. Investigators believe that there are other factors that are not suitable for participating in the experiment.",true,"50 Years",{"count":352,"type":22},248,[75],"This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried powder Injection.",[356],"Healthy","2024-08-08",{"date":359,"type":34},"2024-08-12",{"date":361,"type":34},"2024-08-05",{"date":363,"type":22},"2024-12-31",{"name":40,"class":41},3,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":391},"100545157","phase-1-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-intravesical-instiliations-of-disitamab-vedotin-in-patients-with-high-risk-non-muscular-invasive-bladder-cancer-nmibc-that-express-her2-100545157","NCT06378242","To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","An Single-arm, Multicenter Phase I\u002FII Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","Inclusion Criteria:\n\n1. Voluntary consent to participate in the study and signed the informed consent form.\n2. Male or female, age 18-75 years (including both).\n3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.\n\n   Note: High-risk NMIBC is a high-grade \u002F G3 tumor meeting any of the following:\n\n   a.Carcinoma in situ (CIS) b. T1 stage c. diameter\\>3cm d.Multiple tumors, or recurrent tumors.\n4. Absence of resectable disease（Ta and\u002For T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;\n5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.\n6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Adequate heart, bone marrow, liver, kidney and coagulation function\n\nExclusion Criteria:\n\n* 1\\. Invasive bladder cancer (T2 and above) and \u002F or with regional lymph node and distant metastasis.\n\n  2\\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).\n\n  3\\. Any other antitumor therapy received within 4 weeks before study administration, .\n\n  4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.\n\n  5, Known allergic to DV and its components or to any excipients.",{"count":374,"type":22},24,[75,25],"The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2",[378],"High-risk Non-muscle Invasive Bladder Cancer",[380,381,382],"HER2-expression","High-risk non-muscle invasive bladder cancer","intravesical instiliations","2024-07-09",{"date":385,"type":34},"2024-07-11",{"date":387,"type":34},"2024-06-14",{"date":389,"type":22},"2029-12-31",{"name":40,"class":41},6,{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":88},"100545982","phase-2-to-evaluate-the-efficacy-and-safety-of-disitamab-vedotin-combined-with-toripalimab-sequential-chemotherapy-as-neoadjuvant-treatment-in-patients-with-hr-positive-her2-low-breast-cancer-100545982","NCT06389006","To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer","A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign the informed consent;\n2. Age ≥18 years old (including the threshold value);\n3. Histologically confirmed invasive breast cancer with clinical stage T1c-T2(≥2cm)cN1-2M0 or T3cN0-2M0;\n4. As assessed by the research Center, the subjects can tolerate and plan to undergo radical surgery for breast cancer and have not previously received any anti-tumor systemic therapy for breast cancer;\n5. Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 protein detected by immunohistochemistry (IHC), and no amplification detected by in situ hybridization (ISH) (according to the Breast Cancer HER2 Detection Guidelines 2019); Primary tumor specimens (wax pieces, slices or fresh tissues) can be provided for HER2 detection;\n6. According to the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) 2020 guidelines, tumor tissue estrogen receptor (ER) and progesterone receptor (PgR) expression ≥ 1%;\n7. Histological grade (Nottingham grading system) G3 or G2 with ER expression\n8. ECOG physical status 0 or 1;\n9. At least one measurable lesion according to RECIST v1.1 standard;\n10. Heart function:\n\n    1. New York Heart Association (NYHA) Grade \\\u003C 3;\n    2. left ventricular ejection fraction ≥50%;\n11. Bone marrow or organ function should meet the following criteria within 7 days before the study dose:\n\n    Hemoglobin ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet ≥ 100 ×109\u002FL; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) and glutamic pyruvic transaminase (ALT) ≤ 2.5 times the upper limit of normal value; International normalized ratio (INR) and activated partial thrombin time ≤ 1.5×ULN; Serum creatinine ≤ 1.5×ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin according to Cockcroft-Gault formula method;\n12. Fertile female subjects who meet the following conditions\n\n    1. A serum pregnancy test (minimum sensitivity 25 mIU\u002FmL or equivalent units of β-human chorionic gonadotropin \\[β-hCG\\]) must be negative within 72 hours before the first dosing of the study intervention. Subjects with false positive results who are confirmed not to be pregnant are eligible for study.\n    2. Must agree to contraception for the duration of the study and for at least 6 months after the last dose of investigational drug.\n    3. Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of investigational drug.\n    4. If sexually active and likely to result in pregnancy, continuous use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective from the time of the informed consent and continue until at least 6 months after the last dosing of the investigational drug.\n13. Fertile male subjects who meet the following conditions\n\n    1. Must agree not to donate sperm from the time of signing the informed consent until at least 4 months after the last dose of investigational drug.\n    2. If sexual activity with a fertile person is likely to result in pregnancy, continuous use of at least 2 acceptable forms of contraception, at least 1 of which must be highly effective from the time of the informed consent and continue until at least 4 months after the last dosing of the investigational drug.\n    3. If sexually active with a pregnant or breastfeeding patient, condom use must continue from informed consent until at least 4 months after the last dosing of the investigational drug.\n14. Able to understand trial requirements, willing and able to follow trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Bilateral invasive breast cancer;\n2. Previous history of invasive breast cancer;\n3. Previously had carcinoma in situ of the breast and received adjuvant endocrine therapy within 5 years of surgery;\n4. Use of the investigational drug or major surgery within 4 weeks prior to study dosing;\n5. Have received or plan to receive live or attenuated vaccine within 4 weeks before the start of study dose;\n6. Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation;\n7. Previous treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other Antibody-Drug Conjugates;\n8. Uncontrolled or significant cardiovascular and cerebrovascular diseases\n9. Presence of other treatable or serious lung diseases, including but not limited to active tuberculosis, interstitial lung disease, etc.;\n10. Suffering from an active infection that requires systematic treatment;\n11. Have active autoimmune diseases requiring systemic treatment within the past 2 years, allowing for relevant replacement therapy;\n12. Have a clear past or present history of neurological or psychiatric disorders, including epilepsy or dementia;\n13. Persistent ≥ grade 2 sensory or motor neuropathy;\n14. In the judgment of the investigator, there is a serious concomitant disease that endangers the safety of the subject or interferes with the completion of the clinical study;\n15. Positive HIV test result; Patients with active hepatitis B or C; Persistent coronavirus (COVID-19) infection;\n16. Known hypersensitivity or delayed anaphylaxis to certain components of Disitamab Vedotin, and Toripalimab or Certain components of chemotherapy drugs or similar drugs used in the study;\n17. Suffering from another malignancy within 5 years prior to signing the informed consent",{"count":400,"type":22},79,[25],"The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer",[181],[181,405,406],"HR-positive","HER2 low-expressing","2024-05-21",{"date":409,"type":34},"2024-05-23",{"date":411,"type":34},"2024-04-29",{"date":413,"type":22},"2026-12-31",{"name":40,"class":41},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":422,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":365},"100533541","phase-2-disitamab-vedotin-in-the-treatment-with-her2--expression-subjects-with-locally-advanced-or-metastatic-castration-resistant-prostate-cancer-100533541","NCT06227156","Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer","A Multicenter Open Phase II to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Pathology confirmed prostate adenocarcinoma\n3. Locally advanced or metastatic prostate cancer\n4. PCWG3 criteria-compliant prostate cancer progression occurs during androgen deprivation therapy (or bilateral scrotal excision). Progression will be determined based on at least 1 of the following criteria: PSA progression: defined as 2 consecutive increases in PSA, separated by at least 1 week, relative to the previous reference value. If a confirmed PSA increase is the only indicator of progression, then 1 ng\u002FmL is the minimum starting value; Soft tissue progression: defined as an increase of ≥20% in the sum of the diameters of all target lesions (short-axis for lymph node lesions and long-axis for non-lymph node lesions) relative to the sum of the smallest diameters at the start of treatment or the presence of one or more new lesions; Bone lesion progression: defined as the detection of at least two additional new lesions on bone scan.\n5. Serum testosterone level ≤ 50 ng\u002FdL (or ≤ 1.73 nmol\u002FL), prior to the first study drug administration;\n6. Continuous androgen deprivation therapy (ADT) with LHRH agonists or LHRH antagonists or previous bilateral orchiectomy (surgical debridement) during the study period;\n7. Confirmed HER2 expression (IHC 1+, 2+, 3+), HER2 gene amplification, or HER2 gene mutation;\n8. Subjects were able to provide paraffin blocks or at least 5 paraffin embedded sections (white pieces) for HER2 detection, and the presence of HER2 expression was confirmed by central laboratory tests (immunohistochemistry 1+, 2+, 3+)；\n9. Previous medical androgen deprivation therapy (or bilateral scrotal excision) and new hormone therapy (e.g. abiraterone, enzalutamide) and have developed disease progression\n10. The following criteria should be met within 7 days prior to the first study dose:\n\n    1. haemoglobin ≥ 9 g\u002FdL;\n    2. absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n    3. platelet count ≥ 100 × 109\u002FL;\n    4. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n    5. without liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN; with liver metastasis, alanine aminotransferase and aspartate aminotransferase ≤ 5 × ULN;;\n    6. albumin (ALB) ≥ 25 g\u002FL;\n    7. blood creatinine ≤ 1.5 × ULN, or calculated according to the Cockcroft-Gault formula, creatinine clearance (CrCl) ≥ 50 mL\u002Fmin;\n    8. left ventricular ejection fraction (LVEF) ≥ 50%;\n11. ECOG Physical Status Score of 0-1\n12. Expected survival ≥ 6 months\n13. Subjects whose spouses are of childbearing age must agree to use contraception during the study and for 6 months after the last dose; sperm donation is not permitted during the study and for 6 months after the last dose\n14. Ability to understand and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Systematic chemotherapy, novel hormone therapy, targeted therapy, immunotherapy, or other antitumor therapy (including 5-alpha reductase inhibitors, oestrogens, and medroxyprogesterone, etc.)was administered prior to the initial study drug, and treatment ended within 5 half-lives (or 2 weeks, whichever is shorter) of the initial study drug. Except maintenance castration therapy (LHRH agonists or LHRH antagonists) or bone metastasis therapy(e.g., denosumab, zoledronic acid); In the first study, Chinese medicines with anti-tumor indications were used 2 weeks before administration.\n2. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis (subjects who have been treated for brain metastases may be enrolled in this study provided they have stable disease \\[no evidence of progression as determined by imaging for at least 4 weeks prior to study dosing and and all neurological symptoms have fully recovered\\], there is no evidence of new or enlarging brain metastases, and discontinuation of steroid therapy at least 7 days prior to the first dose of the trial treatment. (This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable or not).\n3. Has received anti-HER2 therapy ;\n4. Major surgery, systemic radiotherapy or biologic therapy within 4 weeks prior to first study drug administration, or minor surgery or local radiotherapy within 1 week prior to enrollment;\n5. Toxicity due to prior antineoplastic therapy that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) Grade 1 or below, with the exception of alopecia and abnormalities in laboratory tests or toxicity associated with LHRH agonists or LHRH antagonists that are not considered by the investigator to pose a safety risk;\n6. Known allergic reactions to components of the study treatment or its analogues\n7. Diagnosis of other malignancies that are expected to affect life expectancy or may interfere with disease assessment. Except for cured non-melanoma skin cancer and superficial bladder cancer\n8. Severe and\u002For persistent infection within 14 days prior to starting the study drug\n9. Serum virological tests: positive HBsAg test result with a positive HBV DNA copy number; positive HCVAb test result; positive HIVAb test result;\n10. Known serious cardiovascular disease, including any of the following: myocardial infarction, thrombotic event, or unstable angina pectoris in the past 3 months; chronic heart failure, New York Heart Association (NYHA) class II or higher; presence of unstable arrhythmia; uncontrolled hypertension;\n11. Combined grade 2 and higher (CTCAE version 5.0) peripheral neuropathy\n12. Presence of other systemic diseases that, in the judgement of the investigator, are not under stable control, including diabetes mellitus, liver cirrhosis, pneumonitis, and obstructive pulmonary disease;\n13. In the judgement of the investigator, there were other circumstances that made participation in the study unsuitable.","MALE",{"count":177,"type":22},[25],"The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.",[427],"Castration-resistant Prostate Cancer",[429,430],"Metastatic Castration-resistant prostate cancer.","HER2- expression",{"date":409,"type":34},{"date":433,"type":34},"2024-04-08",{"date":435,"type":22},"2026-06",{"name":40,"class":41},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":88},"100502413","phase-1-rc108-combine-with-furmonertinib-withwithout-toripalimab-in-patients-with-egfr-mutated-nsclc-100502413","NCT05821933","RC108 Combine With Furmonertinib With\u002FWithout Toripalimab in Patients With EGFR-mutated NSCLC","An Open Single-arm Study to Evaluate the Safety, Tolerability, Efficacy of RC108 in Combination With Furmonertinib and Toripalimab in Patients With Advanced EGFR-mutated NSCLC Ib\u002FII Study","Inclusion Criteria:\n\n1. Voluntarily agree to participate in the study and sign an informed consent form.\n2. Age between 18 and 75 years old (inclusive).\n3. Expected survival period of at least 12 weeks as determined by the investigator.\n4. ECOG performance status of 0 or 1.\n5. For female subjects: must be surgically sterile, postmenopausal, or willing to use a medically accepted contraceptive method (such as an intrauterine device, birth control pills, or condoms) during the study treatment period and for 6 months after the end of the study treatment. A negative pregnancy test within 7 days before study treatment initiation is required, and the subject must not be breastfeeding. For male subjects: must be surgically sterile or willing to use a medically accepted contraceptive method during the study treatment period and for 6 months after the end of the study treatment.\n6. Able to understand the trial requirements, willing and able to comply with trial and follow-up procedures.\n7. Bone marrow function:\n\n   Hemoglobin ≥9 g\u002FdL Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL Platelet count ≥100 × 10\\^9\u002FL\n8. Liver function (based on the clinical trial center's normal values):\n\n   Serum total bilirubin ≤1.5 times the upper limit of normal (ULN) ALT and AST ≤2.5 × ULN and serum total bilirubin ≤1.5 times the ULN if there is no liver metastasis; ALT and AST ≤5 × ULN and serum total bilirubin ≤2 times the ULN if there is liver metastasis.\n9. Kidney function (based on the clinical trial center's normal values):\n\n   Serum creatinine ≤1.5 × ULN, or calculated creatinine clearance (CrCl) by the Cockcroft-Gault formula ≥60 mL\u002Fmin, or measured 24-hour urine CrCl ≥60 mL\u002Fmin.\n10. Heart function:\n\n    NYHA class \\\u003C3 Left ventricular ejection fraction (LVEF) ≥50% QTc interval ≤450 ms\n11. All subjects must have locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histology or cytology.\n12. Must have at least one EGFR-sensitive mutation: exon 19 deletion, L858R mutation in exon 21, T790M mutation in exon 20, G719X mutation in exon 18, S768I mutation in exon 20, or L871Q mutation in exon 21 (inclusion of patients with exon 20 insertion mutation is allowed).\n13. Must have received approved first\u002Fsecond\u002Fthird-generation EGFR-TKI treatment in the past and experienced radiological progression during EGFR-TKI treatment. The patient is allowed to have received other systemic treatments such as chemotherapy and anti-angiogenic agents, regardless of the sequence with EGFR-TKI treatment.\n14. Must provide a tumor tissue sample that meets the central laboratory's testing requirements and has MET (IHC) expression of 1+, 2+, or 3+ as determined by the central laboratory.\n15. Must agree to provide tumor tissue or blood samples collected during or after previous EGFR-TKI treatment-induced radiological progression for EGFR T790M detection or provide the results of EGFR T790M detection in the tumor tissue sample.\n16. Must provide the most recent tumor tissue sample for PD-L1 expression testing, which will be used to stratify subjects for randomization.\n17. At least one measurable lesion according to RECIST 1.1 criteria.\n\nExclusion Criteria:\n\n1. Have used an investigational drug within 4 weeks prior to the start of study dosing.\n2. Have undergone major surgery within 4 weeks prior to the start of study dosing and have not fully recovered.\n3. Received a live vaccine within 4 weeks prior to the start of study dosing or are scheduled to receive any vaccine (except novel inactivated coronavirus vaccine) during the study period.\n4. An arterial\u002Fvenous thrombotic event such as a cardiovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months prior to study dosing.\n5. Clinically significant QT interval prolongation or other arrhythmias or clinical states that, in the opinion of the investigator, have the potential to increase the risk of QT interval prolongation; e.g., resting state ECG QTc \\> 450 ms, complete left bundle branch block, third degree AV block, congenital long QT syndrome, severe hypokalemia, or ongoing medication that can cause QT interval prolongation.\n6. The presence of preexisting or ongoing interstitial lung disease (ILD), drug-induced interstitial lung disease, radiation pneumonia requiring steroid medication, or those with clinical manifestations of suspected interstitial lung disease.\n7. The presence of clinically uncontrollable third interstitial fluid, such as pleural effusion, peritoneal effusion, or pericardial effusion that is clinically symptomatic and cannot be controlled by drainage or other means and is, in the judgment of the investigator, unenrollable.\n8. Suffering from systemic diseases that are not under stable control, including diabetes, hypertension, pulmonary fibrosis, acute and chronic lung disease, interstitial lung disease, cirrhosis of the liver, etc.\n9. Known to have a psychiatric or substance abuse disorder that may have an impact on compliance with trial requirements\n10. Ongoing active infection requiring systemic treatment, such as severe pneumonia, sepsis, etc.\n11. The presence or suspicion of active tuberculosis.\n12. Known presence and activity of any of the following infectious diseases: positive HIV antibody test result; positive HBsAg with positive HBV DNA (i.e., copy number ≥ 2000 copies\u002Fml); positive HCV antibody with positive HCV RNA.\n13. Those who have used a strong inhibitor of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the first dose or a strong inducer of CYP3A4 within 21 days\n14. Have any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study drug, or that will affect the interpretation of the study results, or that places the patient at high risk\n15. Women who are pregnant or breastfeeding or women\u002Fmen who are planning to have children.\n16. Subjects who are estimated to have insufficient patient compliance to participate in this clinical study or who, in the opinion of the investigator, have other factors that make them inappropriate for participation in this study.\n17. Known small cell lung cancer transformation or the presence of a small cell component.\n18. Presence of brain metastases and\u002For cancerous meningitis. Subjects who have been treated for brain metastases may be considered for participation in this study provided that the disease has been stable for at least 3 months, no disease progression has occurred as determined by imaging within 4 weeks prior to the first dose of study treatment, all neurological symptoms have returned to baseline levels, there is no evidence of new or expanding brain metastases, and treatment with radiation, surgery, or steroids has been discontinued at least 28 days prior to the first dose of study treatment . This exception does not include meningeal metastases and carcinomatous meningitis, which should be excluded regardless of their clinical stability.\n19. Other malignancies (except non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated and are considered cured) within 5 years prior to signing the informed consent form.\n20. Known hypersensitivity or delayed allergic reactions to certain components of RC108 for injection, vomitinib or similar drugs, in addition to non-enrollment in Cohort 2 and Cohort 4 for hypersensitivity or delayed allergic reactions to certain components of treprolizumab or similar drugs\n21. Have received drugs targeting the HGF and\u002For MET pathways prior to study administration.\n22. Prior use of PD-1\u002FL1 inhibitors is inadmissible to Cohort 2 and Cohort 4.\n23. Chemotherapy, radiotherapy, immunotherapy and targeted therapy received prior to the start of study dosing less than 4 weeks or less than 5 half-lives (whichever is shorter) from the first dose of this study.\n24. Hormonal therapy received within 2 weeks prior to the start of study dosing for the tumor(s) affected.\n25. Received palliative radiotherapy targeting bone metastases within 2 weeks prior to the start of study dosing.\n26. Having received antitumor herbal therapy within 2 weeks prior to the start of study dosing\n27. Toxicity of prior antitumor therapy that have not recovered to CTCAE \\[version 5.0\\] grade 0-1, with the following exceptions: a. alopecia; b. hyperpigmentation; c. long-term toxicity due to radiotherapy that, in the judgment of the investigator, cannot be recovered.",{"count":445,"type":22},106,[75,25],"an open, single-arm, multicenter phase Ib\u002FII study",[449],"NSCLC","2024-04-09",{"date":452,"type":34},"2024-04-10",{"date":454,"type":34},"2023-09-07",{"date":456,"type":22},"2026-09-01",{"name":40,"class":41},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},"100533125","phase-2-dv-combined-with-cadonilimab-in-subjects-with-her2-expressing-gastric-cancer-and-gastroesophageal-junction-adenocarcinoma-after-progression-on-first-line-therapy-100533125","NCT06221748","DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy","A Randomized，Multicenter, Open-Label，Phase II\u002FIII Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy","Inclusion Criteria:\n\n1. Voluntarily agreed to participate in the study and signed an informed consent form;\n2. Age 18-75 years(both 18 and 75);\n3. Expected survival ≥ 12 weeks\n4. ECOG physical condition score of 0 or 1\n5. Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and\u002For cytology\n6. Subjects will only have failed or been intolerant to prior standard first-line therapy (excluding paclitaxel), with no restriction on prior treatment with a PD-1\u002FPD-L1 inhibitor.\n7. Confirmation of HER2 (IHC 1+, 2+, or 3+) and PD-L1 expression: for Phase II enrolled subjects, results of investigator-confirmed HER2 and PD-L1 expression will be accepted; for Phase III enrolled subjects, HER2 and PD-L1 expression will be accepted only as results from the central laboratory.\n8. Bone marrow function:\n\n   1. Hemoglobin ≥ 9 g\u002FdL (no blood transfusion and no erythropoietin treatment within 2 weeks prior to the examination);\n   2. Absolute neutrophil count ≥ 1.5 × 109\u002FL (must not receive granulocyte colony-stimulating factor treatment within 2 weeks prior to the examination)\n   3. Platelet count ≥ 90 × 109\u002FL (no platelet transfusion or treatment with recombinant human thrombopoietin within 2 weeks before the test);\n9. Liver function (based on normal values at the Clinical Trials Center):\n\n   1. Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n   2. Alanine aminotransferase (ALT) and Mentholatum aminotransferase (AST) ≤ 2.5 × ULN in the absence of hepatic metastases; ALT and AST ≤ 5 × ULN in the presence of hepatic metastases;\n10. Renal function (based on normal values at the Clinical Trials Center):\n\n    Blood creatinine ≤ 1.5 x ULN, or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin calculated by the Cockcroft-Gault formula method, or measured 24-hour urine CrCl ≥ 60 mL\u002Fmin;\n11. Coagulation:\n\n    1. Prothrombin time (PT) ≤ 1.5 x ULN;\n    2. Thrombin time (TT) ≤ 1.5 × ULN;\n    3. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;\n12. Cardiac function:\n\n    * New York Heart Association (NYHA) classification \\\u003C3;\n    * Left ventricular ejection fraction (LVEF) ≥ 50%;\n13. The subject is able to provide specimens for central laboratory testing\u002Freview (at least 5 tissue sections) from the site of the primary or metastatic focus of the tumor within 3 years, preferably specimens taken after failure of first-line therapy;\n14. Have at least one measurable lesion according to RECISTv1.1 criteria;\n15. For female subjects: should be surgically sterilized, post-menopausal, or agree to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) for the duration of the study treatment and for 6 months after the end of the study treatment period; must have had a negative blood pregnancy test within 7 days prior to the study drug administration and must not be breastfeeding; and must not donate eggs for a period of 6 months from the time of signing of the informed consent form to the time of the last administration of the study drug. No egg donation for 6 months. For male subjects: should be surgically sterilized or agree to use a medically approved method of contraception during and for 6 months after the end of study treatment; no sperm donation from the time of signing the informed consent until at least 4 months after the last dose of study drug;\n16. Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Metastatic CNS and\u002For meningeal carcinomatosis；\n2. prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection; prior treatment with cardinolizumab\n3. Prior anti-cancer therapy resulting in toxicity that has not recovered to CTCAE (version 5.0) ≤ Grade 1 (except for hair loss, hyperpigmentation, or other conditions that do not increase the risk of the subject's use of the drug determined by the investigators;\n4. Radical radiotherapy within 3 months prior to study dosing; palliative radiotherapy 2 weeks prior to dosing is permitted, at a dose that meets local diagnostic criteria for palliative care and with radiotherapy coverage of less than 30% of the bone marrow area;\n5. Prior major surgery within 4 weeks before study dose start and incomplete recovery\n6. Received a live vaccine within 28 days prior to the start of the first study dose or plan to receive any vaccine during the study period\n7. Third interstitial effusion associated with clinical symptoms or that requires symptomatic treatment;\n8. Ongoing grade ≥2 sensorimotor or motoneuropathy;\n9. serum virology (based on site normal values):\n\n   1. Positive Hepatitis B virus surface antigen (HBsAg) test result with a positive HBV DNA copy number;\n   2. Positive test result for Hepatitis C Antibody (HCVAb) (enrollment in the study is only possible if the PCR test result for HCV RNA is negative);\n   3. Positive test result for human immunodeficiency virus antibody (HIVAb).；\n10. Serious arterial\u002Fvenous or cardiovascular accidents, such as deep vein thrombosis ( except asymptomatic interstitial vein thrombosis which does not require special treatment), pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, angina pectoris, etc., except for lacunar cerebral infarction, which is asymptomatic and does not require clinical intervention, have occurred in the last 6 months prior to the study drug administration;\n11. Tumor lesions with bleeding tendency (e.g., presence of active ulcerated tumor lesions with a positive fecal occult blood test, history of vomiting blood or black stools within 2 months prior to signing the informed consent form, risk of gastrointestinal hemorrhage in the judgment of the investigator, etc.), or receipt of blood transfusion 4 weeks prior to study drug administration;;\n12. The occurrence of an active or progressive infection requiring systemic treatment (trial drug may be initiated 2 weeks after completion of anti-infective therapy);\n13. The presence of unsteady controlled systemic disease as judged by the investigator, including diabetes and hypertension, hepatocirrhosis, interstitial pneumonitis, and obstructive lung disease.\n14. The existence of active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory agents, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study dosing, allowing for related replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency);\n15. Other malignancy within 5 years prior to the start of study dosing, with the exception of the following: malignancies that are expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);\n16. prior history of allogeneic hematopoietic stem cell transplantation or organ transplantation;\n17. known hypersensitivity to immunosuppressants and any other antibody-drug conjugate and their components and any of the drugs in this study;\n18. women who are pregnant or breast-feeding;\n19. Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition that is unsuitable for the use of the study medication, would interfere with the interpretation of the results of the study, or puts the subject at a high risk of developing a condition;\n20. subjects whose participation in this study is estimated to be insufficiently adherent or who, in the judgment of the investigator, have other factors that make them unsuitable for participation in this study.",{"count":466,"type":22},90,[25,26],"The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.",[470,471],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",[473,474,475],"Gastric cancer","Gastroesophageal junction adenocarcinoma","HER2- expressing","2024-04-01",{"date":478,"type":34},"2024-04-03",{"date":480,"type":34},"2024-02-22",{"date":482,"type":22},"2027-12",{"name":40,"class":41},12,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":505},"100533538","phase-2-neoadjuvant-study-of-dv-in-combination-toripalimab-or-sequence-chemotherapy-in-hr-negative-her2-low-expressing-breast-cancer-100533538","NCT06227117","Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer","A Randomized, Multicenter, Open-Label Phase II Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination Toripalimab or Sequence Chemotherapy in Participants With HR-negative, HER2 Low-expressing Breast Cancer","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form;\n2. Ages≥18 years;\n3. Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC 2+ with no amplification by in situ hybridisation (ISH) (according to the Breast Cancer HER2 Detection Guidelines, 2019 edition) by immunohistochemistry; and specimens from the primary site of the tumour for HER2 detection (wax blocks, biopsies, or fresh tissues are acceptable) are available for HER2 detection\n4. Tumour hormone receptor (HR)-negative, defined as IHC-stained invasive carcinoma with a proportion of cells positive for both ER and PgR nuclear staining of \\\u003C1% according to ASCO\u002FCAP guideline 2020;\n5. Histologically confirmed invasive carcinoma of the breast according to AJCC 8th edition investigator-assessed clinical staging T1cN1-2M0, or T2-3N0-2M0\n6. Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic therapy for breast cancer, as assessed by the research centre;\n7. ECOG PS 0 or 1 point\n8. At least one measurable lesion according to RECIST v1.1 criteria;\n9. Cardiac function: New York Heart Association (NYHA) class \\\u003C3; left ventricular ejection fraction ≥55%;\n10. Bone marrow or organ function, the following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial centre, no transfusion of blood, haematopoietic stimulating factors, albumin or blood products within 14 days prior to the test):\n\n    1. haemoglobin ≥ 90 g\u002FL;\n    2. absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002FL;\n    3. platelets ≥ 100 × 109 \u002FL;\n    4. serum total bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN);\n    5. Albuminous Transaminase (AST) and Albuminous Transaminase (ALT) ≤ 2.5 × ULN;\n    6. International Normalised Ratio (INR) and Activated Fractional Thromboplastin Time ≤ 1.5 × ULN;\n    7. Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin according to the Cockcroft-Gault formula method;\n11. Female subjects of childbearing potential who meet the following criteria:\n\n    1. A serum pregnancy test (minimum sensitivity of 25 mIU\u002FmL or equivalent units of β-human chorionic gonadotropin \\[β-hCG\\]) must be negative within 72 hours prior to the first dose of study intervention. Subjects with false-positive results and confirmed non-pregnancy will be eligible for participation in the study.\n    2. Must agree to contraception for the duration of the study and for at least 6 months after the last dose of study drug .\n    3. Must agree not to breastfeed or donate eggs from the time of signing the informed consent until 6 months after the last dose of study drug .\n    4. If sexually active and likely to result in pregnancy, use of at least 2 acceptable contraceptive methods, at least 1 of which must be highly effective, must be continued from the time of informed consent for at least 6 months after the last dose of study drug\n12. Male subjects of fertile potential who meet the following criteria:\n\n    1. It is necessary to agree not to donate sperm from the time of signing the informed consent form until at least 4 months after the last dose of study drug.\n    2. If sexual intercourse with a person of childbearing potential is likely to result in pregnancy, continuous use of at least 2 acceptable contraceptives, at least 1 of which must be highly effective, beginning at the time of informed consent and continuing until at least 4 months after the last dose of study drug. Beginning at the time of informed consent and continuing for at least 4 months after the last dose of study drug.\n    3. If sex with a pregnant or breastfeeding patient, condom use must be continuous from the time of informed consent and continue until at least 4 months after the last dose of study drug.\n13. Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow up procedural arrangements.\n\nExclusion Criteria:\n\n1. With bilateral invasive breast cancer\n2. Previous history of invasive breast cancer\n3. Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years of surgery\n4. Use of investigational drugs or major surgery within 4 weeks prior to start of study drug administration\n5. Live or live attenuated vaccine administered within 4 weeks prior to the start of study drug administration or planned to be administered during the study period\n6. History of previous allogeneic haematopoietic stem cell transplantation or organ transplantation\n7. Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors and other antibody-coupled drugs;\n8. Uncontrolled or significant cardiovascular disease, including (but not limited to): any of the following within 6 months prior to the first dose: e.g., congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (except for lacunar cerebral infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathy (e.g., dilated cardiomyopathy, Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); history of clinically significant prolongation of the QTc period, grade II type II AV block or grade III AV block or QTc interval (F method) \\>470 msec (women) or \\>450 msec (men); atrial fibrillation (EHRA grade ≥2b); uncontrolled hypertension that is judged by the investigator to be unsuitable; and Hypertension, judged by the investigator to be unsuitable for participation in the study;\n9. History of interstitial lung disease requiring treatment or current severe lung disease including, but not limited to, active tuberculosis, interstitial lung disease;\n10. Ongoing active infection that requires systemic treatment;\n11. Have an active autoimmune disease requiring systemic treatment within the past 2 years (e.g., use of corticosteroids or immunosuppressive drugs, etc.), allowing for relevant replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency)\n12. A clear past or present history of a neurological or psychiatric disorder, including epilepsy or dementia\n13. Ongoing grade ≥2 sensory or motor neuropathy;\n14. Concomitant disease that, in the investigator's judgement, is a serious hazard to the subject's safety or interferes with the subject's ability to complete the clinical study;\n15. Positive HIV test results; patients with active hepatitis B or C (HBsAg positivity accompanied by HBV DNA titres above the upper limit of normal; HCVAb positivity accompanied by HCV RNA titres above the upper limit of normal); and persistent coronavirus (COVID-19) infection.\n16. Hypersensitivity reactions or delayed hypersensitivity reactions to components of Disitamab Vedotin and Toripalimab or analogues are known;\n17. Known hypersensitivity or delayed hypersensitivity to epirubicin, cyclophosphamide, carboplatin preparations or components or similar drugs;\n18. Other malignancy within 5 years prior to signing the informed consent (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumours that have been effectively treated and are considered cured);",{"count":118,"type":22},[25],"The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer",[181],[181,497,406],"HR-negative","2024-03-15",{"date":500,"type":34},"2024-03-19",{"date":502,"type":34},"2023-07-27",{"date":190,"type":22},{"name":40,"class":41},5,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":513,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":530,"locationsCount":484},"100528025","phase-2-a-study-of-rc48-adc-combination-with-zimberelimab-injection-therapies-at-least-first-line-platinum-containing-standard-therapy-failed-with-recurrent-or-metastatic-cervical-cancer-100528025","NCT06155396","A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer","A Single-Arm, Open- Label, Multicenter Phase II Study of RC48-ADC in Combination With Zimberelimab Injection for the Treatment ,at Least First-line Platinum-containing Standard Therapy Failed in HER2-expressing Subject With Recurrent or Metastatic Cervical Cancer","Inclusion Criteria:\n\n1. a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy;\n2. Voluntarily agreed to participate in the study and signed an informed consent form.\n3. Female, age ≥ 18 years\n4. Expected survival ≥ 12 weeks\n5. Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.\n6. Central laboratory confirmation of PD-L1 expression\n7. Measurable disease according to RECIST 1.1 standard\n8. ECOG physical condition 0 or 1 point\n9. Adequate organ function, criteria should be met during the screening period\n\n   1. ANC ≥1,500\u002FµL\n   2. platelet count ≥100,000\u002FμL\n   3. hemoglobin ≥9.0 g\u002FdL\n   4. total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \\>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease\n   5. CrCl ≥50 mL\u002Fmin (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).\n   6. ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases\n   7. LVEF ≥\\>50%\n10. Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.\n11. Willingness and ability to comply with trial and follow-up procedure arrangements.\n\nExclusion Criteria:\n\n1. Have central nervous system metastases and\u002For carcinomatous meningitis.\n2. Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment.\n3. Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-1.\n4. Major surgery with incomplete recovery within 4 weeks prior to start of study dosing.\n5. Serum virology examination (based on the normal value of the research center) :\n\n   1. HBsAg test results were positive, and HBV DNA copy number was positive;\n   2. HCVAb test results were positive (HCV RNA PCR test results were negative only to be included in this study);\n   3. HIVAb tested positive\n6. Have received a live or live attenuated vaccine within 4 weeks prior to the start of study dosing; or plan to receive any vaccine during the study period\n7. Grade 3 or higher heart failure\n8. History of gastrointestinal perforation and\u002For fistula within the previous 6 months\n9. Serious arterial\u002Fvenous thrombotic event or cardiovascular accident within 1 year prior to study drug administration\n10. Presence of active or progressive infection requiring systemic therapy, with severe infection within 4 weeks prior to first dose;\n11. Active TB.\n12. Presence of systemic disease not under stable control as judged by the investigator.\n13. History of interstitial pneumonia, obstructive lung disease, drug-induced pneumonia, radiation pneumonia, idiopathic pneumonia or active pneumonia.\n14. Clinically relevant pyelonephrosis cannot be alleviated by ureteral stents or percutaneous drainage.\n15. Presence of active autoimmune disease requiring systemic therapy within 2 years prior to the start of study drug administration, allowing for relevant alternative therapy.\n16. Other malignancy within 5 years prior to start of study drug administration.\n17. Previous allogeneic haematopoietic stem cell transplantation.\n18. Previous treatment with other Antibody-drug conjugateantibody-coupled drugs.\n19. Known hypersensitivity to the drug vedicilizumab for injection and its components or to Zimberelimab injection and other monoclonal antibodies.\n20. Have any other disease, metabolic abnormality, physical examination abnormality or laboratory test abnormality.\n21. Estimated lack of patient adherence to participate in this clinical study.","FEMALE",{"count":515,"type":22},116,[25],"This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer",[519],"Cervical Cancer",[521,522,523],"HER2-expressing","Recurrent Cervical Cancer","Metastatic Cervical Cancer","2024-02-26",{"date":526,"type":34},"2024-02-28",{"date":528,"type":34},"2024-01-11",{"date":209,"type":22},{"name":40,"class":41},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":293},"100462486","phase-3-a-study-of-rc48-adc-combined-with-toripalimab-for-first-line-treatment-of-urothelial-carcinoma-100462486","NCT05302284","A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma","A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing","Inclusion Criteria:\n\n* Expected survival ≥12 weeks.\n* Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.\n* Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:\n\nParticipants that received neoadjuvant chemotherapy with recurrence \\>6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence \\>6 months from completion of therapy are permitted.\n\n* At least one measurable lesion based on RECIST version 1.1\n* HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.\n* ECOG performance status score: 0 or 1.\n* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.\n\nExclusion Criteria:\n\n* Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.\n* History of major surgery within 4 weeks of planned start of trial treatment.\n* Toxicity from a previous treatment has not returned to Grade 0-1.\n* Prior ADCs or PD-1\u002FPD-L1 inhibitor therapy.\n* Active central nervous system (CNS) metastases.\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.\n* History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.\n* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.\n* Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.",{"count":539,"type":22},452,[26],"This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.",[543,521],"Urothelial Carcinoma",[543,521,545,546],"RC48","First-Line","2023-12-15",{"date":549,"type":34},"2023-12-18",{"date":551,"type":34},"2022-06-14",{"date":553,"type":22},"2028-04-30",{"name":40,"class":41},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":576},"100528024","phase-2-perioperative-disitamab-vedotin-plus-toripalimab-and-xelox-in-gastric-or-gastroesophageal-junction-adenocarcinoma-100528024","NCT06155383","Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.","A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form;\n2. Male or female, ≥18 years;\n3. Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;\n4. Clinical stage cT3-4aN+, no distant metastasis (M0);\n5. According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma;\n6. HER2- expression: IHC 1+, 2+, 3+;\n7. ECOG performance status score of 0 or 1;\n8. Cardiac function: left ventricular ejection fraction ≥50%;\n9. The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center):\n\n   9.1Bone marrow function:\n   1. absolute neutrophil count (ANC) ≥1.5×109\u002FL (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination);\n   2. Platelets ≥100×109\u002FL (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks)\n   3. hemoglobin ≥9g\u002FdL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination);\n\n   9.2Liver function:\n   1. Serum total bilirubin ≤1.5 times the upper limit of normal (ULN);\n   2. alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN;\n\n   9.3 Kidney function:\n\n   a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin according to Cockcroft-Gault formula method; Female: CrCl= (140-age) × weight (kg) × 0.85 72 × serum creatinine (mg\u002FdL) Male: CrCl= (140-age) × weight (kg) × 1.00 72 × serum creatinine (mg\u002FdL)\n\n   9.4 Coagulation function:\n   1. prothrombin time (PT) ≤1.5×ULN;\n   2. thrombin time (TT) ≤ 1.5×ULN;\n   3. activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n10. Female subjects should be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device, contraceptives, or condoms) for 7 days before the first dose and for 6 months after the end of the study treatment period, and not breastfeed. Blood pregnancy tests must be negative within 7 days prior to study enrollment. Male subjects should agree to use at least one medically approved contraceptive method (e.g., condoms, abstinence, etc.) for 7 days prior to initial dosing and up to 6 months after the end of the study treatment period;\n11. Able to understand trial requirements, willing and able to follow trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy (including Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening);\n2. The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；\n3. Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;\n4. Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;\n5. Gastrointestinal perforation\u002Ffistula 6 months before screening;\n6. Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the absorption of capecitabine ;\n7. Peripheral polyneuropathy ≥ NCI Ⅱ grade；\n8. Serum virology examination (based on the normal value of the research center):\n\n   * Positive HBsAg test with positive HBV DNA copy number;\n   * Positive HCVAb test with positive HCV RNA PCR test.\n   * Positive HIVAb test.\n9. Have received live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (except for the novel coronavirus vaccine);\n10. Heart failure rated 3 or higher by the New York College of Cardiology (NYHA);\n11. Cardiac chest pain, defined as moderate pain that restricts daily activities, occurred within 28 days prior to screening. There were serious arteriovenous thrombosis events or cardiovascular and cerebrovascular accidents within six months before dosing, such as deep vein thrombosis (except asymptomatic and untreated intermuscular venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage, and myocardial infarction (except asymptomatic lacunar infarction that did not require clinical intervention);\n12. There is an active or advanced infection that requires systematic treatment (experimental medication may be initiated 2 weeks after the end of anti-infective therapy), such as active tuberculosis;\n13. There are systemic diseases that have not been stably controlled which are determined by investigators, including diabetes, hypertension, cirrhosis, etc.;\n14. A history of lung disease that requires treatment and has the potential to interfere with surgery, including but not limited to interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung disease;\n15. Active autoimmune diseases requiring systemic therapy (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within 2 years prior to dose administration, and replacement therapies (e.g., thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed, and a history of refractory autoimmune disease. Systemic use of steroids within 14 days prior to screening (dose \\> 10 mg\u002Fday prednisone or equivalent dose of other glucocorticoids) or other systemic immunosuppressive therapy;\n16. Other malignancies within 5 years prior to screening, other than those that have been cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);\n17. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n18. Allergies to any of the drugs in this study;\n19. Known deficiency of dipyrimidine dehydrogenase (DPD);\n20. Receiving immunotherapy (including but not limited to interleukin, interferon, thymus hormone) or other investigational drugs within 28 days prior to screening;\n21. Pregnant or lactating women;\n22. Any other disease, metabolic disorder, or abnormal findings upon physical examination or laboratory examination that makes the subject unsuitable for receiving the investigational drug, affects the interpretation of study outcomes, or poses risks to patient safety, as determined by the investigator;\n23. Subject is assessed to be unable or unwilling to comply with the requirements of the protocol.",{"count":466,"type":22},[25],"The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.",[470,471],[521,567,568],"gastric cancer","gastroesophageal junction adenocarcinoma","2023-12-12",{"date":571,"type":34},"2023-12-14",{"date":573,"type":34},"2023-11-27",{"date":209,"type":22},{"name":40,"class":41},11,""]