[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":516},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,42,63,84,108,131,152,171,191,210,232,250,268,287,307,327,346,363,380,403,421,441,459,475,495],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053537","phase-2-skb264-in-combination-with-skb118-for-non-small-cell-lung-cancer-100053537",false,"NCT07697586","SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer","A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.\n* Provide a tumor tissue sample.\n* At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n* Adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.\n* Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and\u002For compression, or active metastases to central nervous system (CNS).\n* Uncontrolled systemic disease as judged by the investigator.\n* Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.\n* Presence of other moderate to severe lung disorders.\n* History of haemorrhagic diathesis or coagulopathy and\u002For clinically significant bleeding symptoms or risks.\n* Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.\n* Active hepatitis b or hepatitis c or co-infection with HBV and HCV.\n* Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Known hypersensitivity to the study drug or any of its components.\n* Pregnant or lactating women.","ALL","18 Years","75 Years",{"count":21,"type":22},206,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.",[28],"NSCLC","NOT_YET_RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":22},"2026-08",{"date":37,"type":22},"2029-08",{"name":39,"class":40},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",2,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100644049","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-skb571-in-recurrent-or-metastatic-hnscc-participants-100644049","NCT07668154","A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.\n* Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is not curable by local therapy and not amenable to curative surgery, with the primary tumor located in the oral cavity, oropharynx, hypopharynx, or larynx.\n* Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.\n* Participants who have adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n* Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n* History or current metastases to central nervous system.\n* Subjects with other malignant tumors within 3 years prior to the first dose.\n* Presence of any cardiovascular and cerebrovascular disorders or risk factors.\n* Presence of uncontrolled systemic disease.\n* Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n* History of interstitial lung disease (ILD) or non-infectious pneumonitis.\n* Presence within 3 months before the first dose of other moderate to severe lung disorders.\n* Tumor invasion or compression of surrounding vital organs and major blood vessels.\n* Unresolved toxicity from prior anti-tumor therapy.\n* Serious infection within 4 weeks before the first dose.\n* Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.\n* Known active pulmonary tuberculosis.\n* Known history of allogeneic organ transplant or hematopoietic stem cell transplant.\n* History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.\n* Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n* Participants who have received other investigational drug treatments within 4 weeks before the first dose.\n* Prior vaccination with a therapeutic anti-tumor vaccine, or any live vaccine within 4 weeks before the first dose, or planned vaccination with a live vaccine during the study.\n* Participants who received systemic corticosteroid therapy with \\>10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before the first dose.\n* Received strong inhibitors or strong inducers of cytochrome P450 (CYP3A4) or breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose or within 5 half-lives of the known drug (whichever is longer).\n* Pregnant or breastfeeding women.\n* Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.\n* Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and\u002For uncertainty in survival assessment, or may affect protocol compliance.\n* Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.",{"count":50,"type":22},30,[25],"This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.",[54],"HNSCC","2026-06-24",{"date":57,"type":33},"2026-06-25",{"date":59,"type":22},"2026-07-31",{"date":61,"type":22},"2028-12-31",{"name":39,"class":40},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100640388","phase-2-a-study-of-skb571-combination-therapy-in-participants-with-non-small-cell-lung-cancer-nsclc-100640388","NCT07622186","A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥ 12 weeks as assessed by the investigator.\n6. Adequate organ and bone marrow function.\n7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with other malignant tumors within 3 years before the first dose of study treatment.\n2. Active or untreated central nervous system (CNS) metastasis.\n3. Current uncontrolled concomitant diseases\n4. Clinically severe lung damage due to complications of lung disorder\n5. Participants with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis\n6. A history of severe skin diseases\n7. Unresolved toxicity from prior anti-tumor therapy\n8. Serious infection within 4 weeks before the first dose of study treatment\n9. Known active pulmonary tuberculosis.\n10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Pregnant or breastfeeding women.\n13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":71,"type":22},150,[25],"This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).",[75],"Non-Small Cell Lung Cancer","2026-05-26",{"date":78,"type":33},"2026-06-03",{"date":59,"type":22},{"date":81,"type":22},"2029-12-31",{"name":39,"class":40},27,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100640725","phase-2-skb315-in-combination-therapy-in-patients-with-advanced-or-metastatic-gc-gej-adenocarcinoma-100640725","NCT07609667","SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC\u002F GEJ Adenocarcinoma","A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","SKB315","Inclusion Criteria:\n\n1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma\n2. No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n3. Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;\n4. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;\n6. Estimated survival ≥ 3 months as judged by the investigator;\n7. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;\n8. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;\n\nExclusion Criteria:\n\n1. Active leptomeningeal disease or uncontrolled brain metastasis\n2. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2\n3. Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;\n4. Patients with active hepatitis B or hepatitis C;\n5. Patients have significant gastric bleeding\n6. The presence of clinically uncontrollable third interspace fluid\n7. Have clinically significant systemic diseases that may adversely affect the safety of the study;\n8. Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.","80 Years",{"count":94,"type":22},80,[25],"This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",[98],"Gastroesophageal Junction Adenocarcinoma","2026-05-20",{"date":101,"type":33},"2026-05-27",{"date":103,"type":22},"2026-06-30",{"date":105,"type":22},"2029-06-30",{"name":39,"class":40},1,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":41},"100628312","phase-1-skb103-for-injection-in-advanced-solid-tumors-100628312","NCT07459998","SKB103 for Injection in Advanced Solid Tumors","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants voluntarily joined this study and signed an informed consent form.\n2. The age at the time of signing the informed consent form must be between 18 and 75 years.\n3. Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.\n4. Participants should provide tumor tissue samples for biomarker testing as much as possible.\n5. Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.\n6. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.\n7. Expected survival period ≥ 12 weeks.\n8. Participants have sufficient bone marrow, liver, kidney, and coagulation functions.\n9. Male and female participants must agree to use highly effective contraceptive methods during the study period.\n\nExclusion Criteria:\n\n1. Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, and active central nervous system (CNS) metastasis.\n2. Patients with other malignant tumors within 3 years before the first administration.\n3. There are serious heart or vascular diseases or high-risk factors present.\n4. According to researchers' judgment, it is an uncontrollable systemic disease.\n5. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\\>1 time\u002Fweek).\n6. History of interstitial lung disease or non infectious pneumonia.\n7. There are other lung diseases that may interfere with drug-related pulmonary toxicity.\n8. Severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal diseases that hinder\u002Fdelay corneal healing.\n9. There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.\n10. Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.\n11. The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.\n12. Serious infection occurred within 4 weeks before the first administration.\n13. Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).\n14. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n15. Known active pulmonary tuberculosis.\n16. Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n17. History of allergies to any components of SKB103 injection or severe hypersensitivity reactions to other monoclonal antibodies.\n18. Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before the first administration;\n19. Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.\n20. Have undergone major surgical procedures or suffered serious injuries within 4 weeks prior to the first administration of medication.\n21. Those who have received treatment with other clinical investigational drugs within 4 weeks prior to their first administration.\n22. Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 4 weeks prior to their first treatment with the investigational drug.\n23. Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with\\>10 mg\u002Fday prednisone within 2 weeks prior to the first dose.\n24. Within 14 days before the first administration or within 5 half lives of known drugs (whichever is longer), she received a strong inhibitor or strong inducer of cytochrome P450 or a breast cancer resistance protein (BCRP) inhibitor.\n25. Pregnant or lactating women.\n26. Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.\n27. Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.\n28. Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.",{"count":116,"type":22},277,[118,25],"PHASE1","This is a phase 1\u002F2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.",[121],"Advanced Solid Tumors","RECRUITING","2026-05-14",{"date":125,"type":33},"2026-05-18",{"date":127,"type":33},"2026-04-23",{"date":129,"type":22},"2030-12-31",{"name":39,"class":40},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":41},"100610655","phase-2-a-phase-ii-study-of-skb571-in-patients-with-lung-cancer-100610655","NCT07230405","A Phase II Study of SKB571 in Patients With Lung Cancer","A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Subjects aged 18-75 years at the time of signing the informed consent form\n2. Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC .\n3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.\n4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.\n5. Subjects who are assessed by the investigator to have an expected survival of ≥ 12 weeks.\n6. Subjects who have adequate organ function.\n7. Subjects who have recovered from all toxicities due to prior therapy .\n8. Male and female subjects must agree to use highly effective contraception methods during the study treatment.\n9. Subjects who voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with known active or untreated central nervous system (CNS) metastases.\n2. Subjects with other malignant tumors within 3 years prior to the first dose.\n3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.\n4. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.\n5. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.\n6. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.\n7. Subjects with clinically severe lung injuries due to pulmonary complications.\n8. History of noninfectious pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD\n9. Subjects with major surgery within 28 days prior to the first dose.\n10. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.\n11. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.\n12. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.\n13. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.\n14. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \\> 10 mg\u002Fd or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.\n15. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.",{"count":139,"type":22},295,[25],"This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.",[143],"Lung Cancer (Non-Small Cell)","2026-05-10",{"date":146,"type":33},"2026-05-12",{"date":148,"type":33},"2026-01-19",{"date":150,"type":22},"2028-01-19",{"name":39,"class":40},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":107},"100638824","phase-1-skb118-injection-in-advanced-solid-tumors-100638824","NCT07586943","SKB118 Injection in Advanced Solid Tumors","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB118 Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants voluntarily joined this study and signed an informed consent form.\n2. The age at the time of signing the informed consent form must be between 18 and 75 years.\n3. Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.\n4. Participants should provide tumor tissue samples for biomarker testing as much as possible.\n5. Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.\n6. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.\n7. Expected survival period ≥ 12 weeks.\n8. Participants have sufficient bone marrow, liver, kidney, and coagulation functions.\n9. Male and female participants must agree to use highly effective contraceptive methods during the study period.\n\nExclusion Criteria:\n\n1. Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, and active central nervous system (CNS) metastasis.\n2. Patients with other malignant tumors within 3 years before the first administration.\n3. There are serious heart or vascular diseases or high-risk factors present.\n4. According to researchers' judgment, it is an uncontrollable systemic disease.\n5. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\\>1 time\u002Fweek).\n6. History of interstitial lung disease or non infectious pneumonia.\n7. There are other lung diseases that may interfere with drug-related pulmonary toxicity.\n8. There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.\n9. Screening imaging shows that the tumor encases important blood vessels or exhibits obvious necrosis or cavities, and the investigator determines that study enrollment would pose a risk of bleeding.\n10. Previous or concurrent gastrointestinal perforation, surgical and wound healing complications, and bleeding events.\n11. The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.\n12. Have experienced ≥ Grade 3 immune-related adverse events (irAEs) during prior immunotherapy.\n13. Serious infection occurred within 4 weeks before the first administration.\n14. Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).\n15. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n16. Known active pulmonary tuberculosis.\n17. Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n18. History of allergies to any components of SKB118 injection or severe hypersensitivity reactions to other monoclonal antibodies.\n19. Having an active autoimmune disease that required systemic treatment within the past two years.\n20. Active or prior history of confirmed inflammatory bowel disease.\n21. Currently using or having recently used aspirin therapy.\n22. Received oral or parenteral anticoagulants or thrombolytic agents within 2 weeks prior to the first dose.\n23. Previous treatment with antibodies or drugs targeting T-cell co- stimulation or checkpoint pathways, as well as cell therapy.\n24. Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before the first administration.\n25. Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.\n26. Have undergone major surgical procedures or suffered serious injuries within 4 weeks prior to the first administration of medication.\n27. Those who have received treatment with other clinical investigational drugs within 4 weeks prior to their first administration.\n28. Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 4 weeks prior to their first treatment with the investigational drug.\n29. Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with\\>10 mg\u002Fday prednisone within 2 weeks prior to the first dose.\n30. Pregnant or lactating women.\n31. Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.\n32. Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.\n33. Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.",{"count":160,"type":22},332,[118,25],"This is a phase 1\u002F2 clinical study to evaluate the safety and efficacy of SKB118 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.",[121],"2026-05-07",{"date":123,"type":33},{"date":167,"type":22},"2026-06",{"date":169,"type":22},"2030-12",{"name":39,"class":40},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":178,"minAge":18,"maxAge":19,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":41},"100627460","phase-2-a-study-of-skb518-as-monotherapy-or-combination-therapy-in-patients-with-advanced-gynecological-malignant-tumors-100627460","NCT07448922","A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignancies","Inclusion Criteria:\n\n1. Provide signed written informed consent and demonstrate understanding of and agreement to comply with study requirements and the study visit schedule.\n\n   Age\n2. Be ≥ 18 years and ≤ 75 years of age at the time of informed consent signing.\n\n   Participant Type and Disease Characteristics\n3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 2 weeks prior to first dose administration.\n4. Have a cytologically or histologically confirmed gynecologic malignancy.\n\n   * Cohort A: Ovarian cancer (OC) (including fallopian tube cancer and primary peritoneal cancer) with epithelial ovarian carcinoma histology, previously treated with 2-4 lines of systemic therapy, excluding primary platinum-resistant ovarian cancer (defined as disease recurrence or progression during first-line platinum-containing therapy, or disease recurrence or progression occurring \\\u003C182 days from the last platinum-containing therapy in the first line).\n   * Cohort B: Cervical cancer or endometrial cancer that has failed standard therapy or is intolerant to standard therapy, or for which no standard therapy exists.\n   * Cohort C: Platinum-sensitive ovarian cancer (PSOC) previously treated with 2-4 lines of systemic therapy.\n   * Cohort D: PSOC previously treated with 1-2 lines of systemic therapy.\n   * Cohort E Safety Lead-in Phase: PSOC previously treated with 2-4 lines of systemic therapy.\n   * Cohort E Expansion Phase: PSOC participants who have achieved Complete Response (CR),Partial Response (PR), or Stable Disease (SD) after 2 lines of therapy (platinum-based doublet regimen combined with bevacizumab), and require randomization within 8 weeks after the last dose.\n\n   Participants in Cohorts A, C, D, and E with known breast cancer susceptibility gene (BRCA) mutations must have received poly(ADP-ribose) polymerase (PARP) inhibitor therapy, unless contraindicated.\n\n   Note:\n   1. PSOC is defined as radiographic progression\u002Frecurrence occurring ≥6 months after the last platinum-containing chemotherapy, i.e., the interval from the date of the last platinum therapy to radiographic evidence of disease progression per RECIST v1.1 should be ≥6 months (182 days).\n   2. Line counting rules for OC are as follows:\n\n      * Adjuvant ± neoadjuvant therapy is considered 1 line of systemic antineoplastic therapy.\n      * Maintenance therapy (e.g., bevacizumab, PARP inhibitors) as part of frontline antineoplastic therapy is not counted as a separate line.\n      * Treatment regimen changes due to intolerance toxicity rather than disease progression are considered part of the same prior treatment line and are not counted as a separate line.\n5. Provide approximately 10-13 unstained consecutive tumor tissue slides during the screening period for gene expression level testing (preferably from recently obtained tissue). If fresh tumor tissue samples are unavailable, archived tumor tissue samples obtained within 2 years prior to first study dose administration may be provided. If a participant is unable to provide archived tumor tissue samples within 2 years prior to first dose, or unable to provide a sufficient number of unstained consecutive tumor tissue slides, the investigator must discuss with the medical monitor to determine whether earlier obtained tumor tissue samples or a reduced number of slides may be accepted. Fine-needle aspiration biopsy specimens or core biopsies are insufficient for biomarker testing. Cell smears from centrifuged thoracic\u002Fabdominal\u002Fpelvic\u002Fpericardial effusion drainage, and bone lesions without soft tissue components or from decalcified bone tumor specimens are also unacceptable.\n6. Have at least one target lesion per RECIST v1.1 criteria, accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast preferred) with a longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and the lesion must be suitable for repeated accurate measurement. Lesions located in previously irradiated areas or that have undergone biopsy may serve as measurable target lesions if there is documented evidence of disease progression per RECIST v1.1. Brain lesions are not considered target lesions.\n7. Have an estimated life expectancy ≥12 weeks as assessed by the investigator.\n8. Demonstrate adequate bone marrow, hepatic, renal, and coagulation function based on laboratory tests performed within 7 days prior to first dose (hematology tests required within 3 days prior to first dose) \\[supportive treatments, including transfusions, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietin (TPO), TPO receptor agonists (TPO-RA), and interleukins, are not permitted within 14 days prior to first dose\\]:\n\n   1. Hematology: Absolute neutrophil count (NEUT) ≥1.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n   2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤5×ULN; Total bilirubin (TBIL) ≤1.5×ULN and direct bilirubin (DBIL) ≤1.5×ULN;\n   3. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or calculated creatinine clearance ≥60 mL\u002Fmin using the Cockcroft-Gault formula (see Appendix 4); Urinalysis indicating urine protein \\\u003C2+; for participants with urine protein ≥2+ on baseline urinalysis, a 24-hour urine collection should be performed with protein content \\\u003C1 g in 24 hours (if both testing methods are used, the 24-hour urine collection value will be used to determine eligibility);\n   4. Coagulation function: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤1.5×ULN.\n9. Have a left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO) within 28 days prior to first study drug administration.\n10. Have recovered from all toxicities due to prior therapy (i.e., improved to Grade 0 or 1, or to levels specified in the eligibility criteria). Participants with unresolved, stable chronic (\\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.\n\n    Gender and Contraceptive Requirements\n11. Participants must agree to use highly effective contraception during study treatment.\n\nNote: The reliability of abstinence as required in the eligibility criteria must be evaluated based on the duration of the clinical study and the participant's preferred and usual lifestyle. Periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, or post-ovulation method) is not an acceptable contraceptive method.\n\nFemale participants eligible for study participation must be non-pregnant (see Appendix 3), non-lactating, and meet at least one of the following conditions:\n\n* Not a woman of childbearing potential (WOCBP) as defined in Appendix 3. OR\n* A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 from the time of informed consent signing through at least 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\nPrior\u002FCurrent Study Experience\n\n1. Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up periods of interventional studies.\n\n   Disease Characteristics\n2. For participants with ovarian cancer, mixed tumors containing sarcomatous components or borderline ovarian tumors.\n\n   \\- For participants in Cohorts C-E, mixed tumors containing high-grade serous carcinoma components and other components, or endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of the above histological types, or low-grade\u002Fborderline ovarian tumors.\n\n   Prior\u002FConcomitant Therapy\n3. Prior receipt of any of the following treatments:\n\n   a) Any drug therapy targeting topoisomerase I, including irinotecan, topotecan hydrochloride for injection, antibody-drug conjugates (ADCs) containing topoisomerase I, etc.\n4. Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy, etc. For oral PARP inhibitors and traditional Chinese medicines indicated for antineoplastic therapy, the washout period is 2 weeks or 5 half-lives, whichever is longer.\n5. Receipt of strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors (see Appendix 8) within 2 weeks prior to first dose or within 5 half-lives of the known drug, whichever is longer.\n6. Receipt of live vaccine vaccination within 4 weeks prior to first study drug administration, or planned receipt of any live vaccine during the study.\n7. Persistence of adverse reactions from prior antineoplastic therapy that have not resolved to Grade 0, Grade 1, or baseline status per NCI-CTCAE v5.0 criteria prior to first study drug administration. Participants with unresolved, stable chronic (\\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.\n8. Major surgery (craniotomy, thoracotomy, or laparotomy, and other surgical types considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks prior to first study drug administration, or anticipated major surgery during the study, or presence of serious unhealed wounds, trauma, or ulcers, etc.\n\n   Note: Palliative local surgical treatment for isolated lesions is acceptable.\n9. Palliative radiotherapy within 2 weeks prior to first drug administration, or definitive radiotherapy within 4 weeks prior to first drug administration.\n10. Any condition requiring systemic corticosteroid therapy (dose \\>10 mg\u002Fday prednisolone or equivalent) or other immunosuppressive therapy within 14 days prior to first study drug administration. Participants receiving intranasal, inhaled, topical, or local glucocorticoid injections (e.g., intra-articular injections), or glucocorticoids as prophylaxis for hypersensitivity reactions may be enrolled.\n\n    Medical Conditions\n11. Known symptomatic central nervous system (CNS) metastasis and\u002For spinal cord compression and\u002For carcinomatous meningitis, or history of leptomeningeal carcinomatosis. Participants with asymptomatic CNS metastases (no neurological symptoms, no corticosteroid treatment required, and all metastatic lesions ≤1.5 cm in diameter) or with brain metastases that have been treated and are stable may be considered for enrollment if all of the following criteria are met: (a) Measurable disease outside the CNS; (b) No midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastases; (c) Stable condition for at least 4 weeks with no new or enlarging metastases (clearly documented by clinical evidence); (d) Discontinuation of corticosteroids or anticonvulsants at least 2 weeks prior to first study drug administration. CNS lesions should be monitored regularly during the study.\n12. History of corticosteroid-treated pneumonitis, or history of other clinically significant pulmonary disease (e.g., interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or participants with suspected such disease on imaging during screening; clinically significant pulmonary function impairment due to concurrent pulmonary disease, including but not limited to: any serious underlying pulmonary disease (e.g., severe asthma, severe chronic obstructive pulmonary disease, or restrictive lung disease), or any autoimmune disease, connective tissue disease, or inflammatory disease potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n13. Presence of the following conditions:\n\n    1. Infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first study drug administration; serious infection within 4 weeks prior to first study drug administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n    2. Human immunodeficiency virus (HIV) infection, or HIV-positive (HIV 1\u002F2 Ab positive);\n    3. Acute or chronic active hepatitis B, defined as positive hepatitis B surface antigen (other antigen\u002Fantibody results unrestricted) or positive hepatitis B core antibody only (negative hepatitis B surface antibody and negative hepatitis B e antibody), with HBV DNA copy number ≥1×10⁴ copies\u002FmL or ≥2000 IU\u002FmL; acute or chronic active hepatitis C, defined as positive hepatitis C virus (HCV) antibody with HCV RNA titer above the lower limit of detection;\n    4. Symptomatic coronavirus disease 2019 (COVID-19) infection requiring treatment or resulting in hospitalization, such as fever, dyspnea, nausea, vomiting, diarrhea, etc.;\n    5. Active tuberculosis infection, or currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to first study drug administration;\n    6. Active syphilis infection or latent syphilis requiring treatment;\n    7. Uncontrolled myocarditis, or symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc., QTc interval \\>480 ms, personal or family history of congenital long\u002Fshort QT syndrome;\n    8. Uncontrolled hypertension despite standardized treatment or uncontrolled despite standardized treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);\n    9. Gastrointestinal tract \\[referring to the muscular tube from mouth to anal canal, including oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal\\] or tracheal lumen stent implantation;\n    10. Significant malnutrition, such as requiring intravenous nutritional supplementation due to malnutrition; except if malnutrition was corrected \\>4 weeks prior to first study treatment.\n    11. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to first study drug administration (thrombosis due to implanted venous access ports or catheter-related thrombosis, or superficial venous thrombosis are not considered serious thromboembolism).\n    12. History of any arterial thromboembolic event within 6 months prior to first study drug administration, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n    13. Bleeding within 3 months prior to first study drug administration that was life-threatening, required transfusion, or required invasive treatment.\n    14. Symptomatic pelvic\u002Fabdominal effusion (excluding pelvic\u002Fabdominal effusion due to ovarian cancer itself), pleural effusion, or pericardial effusion requiring intervention (participants with stable, controlled effusion are permitted, defined as no significant increase in effusion volume and no clinical symptoms for at least 7 days with drainage tube removed or without drainage).\n    15. Participants with biliary obstruction unless local treatment for the obstruction has been performed (e.g., endoscopic stent placement or percutaneous transhepatic drainage) and TBIL has decreased to below 1.5×ULN.\n    16. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or higher cirrhosis.\n    17. History of prior gastrointestinal perforation or fistula formation, unhealed gastrointestinal obstruction, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer), participants with recurrent gastrointestinal obstruction (defined as ≥2 episodes of gastrointestinal obstruction within one year, or prior gastrointestinal obstruction in 2 consecutive years), or history of the following conditions: extensive bowel resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n    18. Clinically significant proteinuria.\n    19. History of severe dry eye, meibomian gland disease (MGD) and\u002For blepharitis, keratoconjunctivitis sicca (KSC), corneal disorders causing non-healing or delayed healing of the cornea, or macular disorders. Or determination of keratoconjunctivitis and\u002For corneal ulcer on ophthalmologic examination during screening, and presence of active or chronic corneal disease, other active eye disease requiring continuous treatment, or any clinically significant corneal disease preventing adequate monitoring of drug-induced keratopathy.\n14. Known hypersensitivity to study drug or any of its components \\[including polysorbate 80 (II)\\], or history of serious allergic reaction to other monoclonal antibodies; known history of platinum hypersensitivity for Cohort C; known history of platinum or bevacizumab hypersensitivity for Cohort D; known history of bevacizumab hypersensitivity for Cohort E; and hypersensitivity to both CT and MRI contrast agents, or inability to undergo contrast-enhanced CT and contrast-enhanced MRI for any reason.\n15. History of immunodeficiency disorders, including congenital or acquired immunodeficiency diseases.\n16. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n17. Pregnant or lactating women.\n\n    Tumor History\n18. Participants with known other malignancies progressing within the past 5 years or requiring active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ with no evidence of disease recurrence.\n19. Tumor invasion of surrounding vital organs or tissues (e.g., mediastinal great vessels, superior and inferior vena cava, pericardium, heart, trachea, esophagus, etc.) and\u002For risk of gastrointestinal, respiratory, or other fistulas due to any cause.\n\n    Other Exclusion Criteria\n20. Presence of other acute or chronic diseases or laboratory abnormalities that may increase the risk of study participation or administration, or interfere with interpretation of study results; presence of neurological, psychiatric, or social conditions affecting trial compliance, significantly increasing the risk of adverse events, or affecting the participant's ability to provide written informed consent.\n21. Acute or chronic diseases or laboratory abnormalities that the investigator judges unsuitable for study participation, or any condition that the investigator believes interferes with evaluation of study drug, participant safety, or interpretation of study results, or any other condition that the investigator believes makes the participant unsuitable for this study.","FEMALE",{"count":180,"type":22},280,[25],"This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies.\n\nThis study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer.\n\nStudy hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.",[184],"Advanced Gynecological Malignancies",{"date":146,"type":33},{"date":187,"type":33},"2026-04-08",{"date":189,"type":22},"2028-09-30",{"name":39,"class":40},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100466288","phase-2-skb264-combinatiton-therapy-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancer-100466288","NCT05351788","SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.","A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;\n2. Histologically and cytologically confirmed NSCLC;\n3. Cohort 1: Patients with locally advanced\u002Fmetastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced\u002Fmetastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced\u002Fmetastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.\n4. Provide fresh or archival tumor tissue for biomarker testing and analysis;\n5. Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled;\n6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks;\n7. Adequate organ and bone marrow function\n8. For female patients of childbearing age and male patients with partners of childbearing age, they must use effective medical contraception during the study treatment period and for 6 months after the last dose of study medication (see Annex for specific contraceptive measures);\n9. Each patient must voluntarily agree to participate in the study, sign the informed consent form, and comply with the protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n1. Presence of small cell lung carcinoma (SCLC) components in histological pathology;\n2. History of other malignancies;\n3. Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;\n4. Presence of active central nervous system (CNS) metastases;\n5. Imaging (CT or MRI) shows that the tumor surrounds important blood vessels, or the investigator determines that the tumor is most likely to invade important blood vessels during the subsequent study to cause fatal major hemorrhage;\n6. Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment, including any of the following:\n7. Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease;\n8. Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage;\n9. Certain viral infections including active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); or positive syphilis antibody test;\n10. Known active tuberculosis;\n11. Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies;\n12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n13. Pregnant or lactating women;\n14. Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc\n15. Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.",{"count":199,"type":22},110,[25],"The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.",[203],"Non-small Cell Lung Cancer",{"date":146,"type":33},{"date":206,"type":33},"2022-05-20",{"date":208,"type":22},"2026-12",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":231,"locationsCount":7},"100636344","phase-2-a-study-of-skb571-in-participants-with-gastrointestinal-tumors-100636344","NCT07564466","A Study of SKB571 in Participants With Gastrointestinal Tumors","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants must have histologically or cytologically confirmed gastrointestinal tumors.\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥ 12 weeks as assessed by the investigator.\n6. Adequate organ and bone marrow function.\n7. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n8. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with other malignant tumors within 3 years before the first dose of study treatment.\n2. History or current metastases to central nervous system.\n3. Current uncontrolled concomitant diseases\n4. Clinically severe lung damage due to complications of lung disorder\n5. Participants with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis\n6. A history of severe skin diseases\n7. Unresolved toxicity from prior anti-tumor therapy\n8. Serious infection within 4 weeks before the first dose of study treatment\n9. Known active pulmonary tuberculosis.\n10. Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Pregnant or breastfeeding women.\n13. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":218,"type":22},120,[25],"This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.",[222],"Gastrointestinal Tumors",[224],"Gastrointestinal tumors","2026-05-06",{"date":227,"type":33},"2026-05-11",{"date":103,"type":22},{"date":230,"type":22},"2028-06-30",{"name":39,"class":40},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":107},"100618261","phase-2-phase-ii-study-of-sacituzumab-tirumotecan-in-combination-with-osimertinib-or-sacituzumab-tirumotecan-for-neoadjuvant-treatment-in-patients-with-resectable-epidermal-growth-factor-receptor-egfr-mutated-non-small-cell-lung-cancer-100618261","NCT07329322","Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","A Randomized, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib or as Monotherapy for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed NSCLC.\n3. No prior systemic anti-tumor therapy.\n4. No prior local therapy for NSCLC.\n5. Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.\n7. At least one target lesion as assessed by the investigator according to RECIST v1.1.\n8. Life expectancy ≥ 24 weeks.\n9. Adequate organ and bone marrow function.\n10. For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose.\n11. Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n1. Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%.\n2. Participants with other malignant tumors within 3 years prior to randomization.\n3. Resting electrocardiogram (ECG) showing clinically significant abnormal results.\n4. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n5. Uncontrolled systemic diseases in the investigator's judgment.\n6. History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis.\n7. Clinically severe lung damage due to complications of lung disorder.\n8. Participants who have received systemic corticosteroids therapy with \\> 10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before randomization.\n9. Known active pulmonary tuberculosis.\n10. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.\n11. Active hepatitis B.\n12. Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n13. Known hypersensitivity to osimertinib, sacituzumab tirumotecan, or any of their components (including but not limited to polysorbate-20); known history of severe hypersensitivity to other biologics.\n14. Have received a live vaccine within 30 days prior to randomization, or plan to receive a live vaccine during the study.\n15. Pregnant or lactating women.\n16. Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that the investigator considers unsuitable for participation in this study.",{"count":240,"type":22},60,[25],"The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib or as monotherapy for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer.",[75],{"date":227,"type":33},{"date":246,"type":33},"2026-03-30",{"date":248,"type":22},"2032-10-31",{"name":39,"class":40},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":107},"100616630","phase-2-a-phase-ii-clinical-study-of-skb571-as-monotherapy-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-with-met-abnormalities-100616630","NCT07308106","A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants with histologically or cytologically confirmed NSCLC.\n3. Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.\n4. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.\n6. Life expectancy ≥ 3 months as assessed by the investigator.\n7. Adequate organ and bone marrow function.\n8. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n9. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with known active central nervous system (CNS) metastasis, and\u002For carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.\n2. Participants with other malignant tumors within 3 years prior to the first dose.\n3. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n4. Presence of severe and\u002For uncontrolled concomitant diseases.\n5. Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.\n6. Clinically severe lung damage due to complications of lung disorder.\n7. Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.\n8. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1.\n9. Known active pulmonary tuberculosis.\n10. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n11. Active hepatitis B and hepatitis C.\n12. Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n13. Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.\n14. Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.\n15. Serious infection within 4 weeks before the first dose.\n16. Participants who have received systemic corticosteroid therapy with \\> 10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before the first dose of study treatment.\n17. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.\n18. Pregnant or breastfeeding women.\n19. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors.\n20. Any condition that, in the investigator's opinion, interferes with the evaluation of study treatment, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.",{"count":240,"type":22},[25],"The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.",[261],"Non-small Lung Cancer",{"date":227,"type":33},{"date":264,"type":33},"2026-04-03",{"date":266,"type":22},"2029-03-31",{"name":39,"class":40},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":284,"leadSponsor":286,"locationsCount":41},"100634867","phase-1-skb565-for-injection-in-advanced-solid-tumors-100634867","NCT07545265","SKB565 for Injection in Advanced Solid Tumors","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB565 for Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants voluntarily joined this study and signed an informed consent form.\n2. The age at the time of signing the informed consent form must be between 18 and 75 years.\n3. Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.\n4. Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.\n5. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.\n6. Expected survival period ≥ 12 weeks.\n7. Participants have sufficient bone marrow, liver, kidney, and coagulation functions.\n8. Male and female participants must agree to use highly effective contraceptive methods during the study period.\n\nExclusion Criteria:\n\n1. Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, and active central nervous system (CNS) metastasis.\n2. Patients with other malignant tumors within 3 years before the first administration.\n3. There are serious heart or vascular diseases or high-risk factors present.\n4. According to researchers' judgment, it is an uncontrollable systemic disease.\n5. There are pleural, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.\n6. History of interstitial lung disease or non infectious pneumonia.\n7. There are other lung diseases that may interfere with drug-related pulmonary toxicity.\n8. Severe dry eye syndrome, severe conjunctivitis, severe meibomian gland disease and\u002For blepharitis, or a history of corneal diseases that hinder\u002Fdelay corneal healing.\n9. Presence of esophagotracheal fistula or esophagoaortic fistula, or tumor invasion or compression of surrounding vital organs and blood vessels accompanied by corresponding clinical symptoms.\n10. Within 3 months prior to the first administration, there have been intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.\n11. The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.\n12. Serious infection occurred within 28 days prior to the first administration.\n13. Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).\n14. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n15. Known active pulmonary tuberculosis.\n16. Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n17. History of allergies to any components of SKB565 injection or severe hypersensitivity reactions to other monoclonal antibodies.\n18. Received chemotherapy, immunotherapy, biological therapy, or other large-molecule antitumor drugs within 28 days prior to the first administration. Received small-molecule targeted therapy or approved antitumor Chinese patent medicine preparations within 14 days prior to the first administration.\n19. Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.\n20. Have undergone major surgical procedures or suffered serious injuries within 28 days prior to the first administration.\n21. Those who have received treatment with other clinical investigational drugs within 28 days prior to the first administration.\n22. Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to the first administration.\n23. Pregnant or lactating women.\n24. Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.\n25. Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.\n26. Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.",{"count":276,"type":22},180,[118,25],"This is a phase I\u002FII clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.",[121],"2026-05-05",{"date":282,"type":33},"2026-05-08",{"date":167,"type":22},{"date":285,"type":22},"2029-05",{"name":39,"class":40},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":294,"sex":17,"minAge":18,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":306,"locationsCount":41},"100630468","phase-1-a-study-of-skb575-hbm7575-injection-in-healthy-participants-and-atopic-dermatitis-participants-100630468","NCT07488065","A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants","A Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants","Inclusion Criteria:\n\nPhase Ia healthy participants must meet all of the following inclusion criteria to be enrolled:\n\n1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.\n2. Age at the time of signing the informed consent form is 18-55 years (inclusive), any gender.\n3. Male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg; body mass index \\[BMI\\] is 18.0-28.0 kg\u002Fm² (inclusive).\n4. No clinically significant abnormalities.\n\nPhase Ib participants with moderate to severe AD must meet all of the following inclusion criteria to be enrolled:\n\n1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.\n2. Age at the time of signing the informed consent form is 18-70 years (inclusive), any gender.\n3. Participant weight must be ≥ 45.0 kg.\n4. At screening, the diagnosis of AD meets the American Dermatology Consensus Criteria (2014) (see Appendix 4) and disease duration is ≥ 1 year; and at both screening and randomization, all of the following conditions are satisfied:\n\n   1. EASI ≥ 16 at screening and baseline visits;\n   2. IGA ≥ 3 (on a 0 4 IGA scale, where 3 = moderate, 4 = severe) at screening and baseline visits;\n   3. Body surface area (BSA) of lesions ≥ 10% at screening and baseline visits.\n5. Prior to screening, the participant has received at least 4 weeks of potent or 2 weeks of super potent topical corticosteroids (or systemic corticosteroids), or topical calcineurin inhibitor.\n\nExclusion Criteria:\n\n1. History of any clinically significant disease of the cardiovascular, hematological, hepatic, renal, digestive, neurological, respiratory, or psychiatric systems, or metabolic disorders, or any other disease or physiological condition that may interfere with the trial results.\n2. History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis.\n3. Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are unsuitable for subcutaneous injection.\n4. Clinical signs of active infection within 4 weeks prior to randomization, including but not limited to urogenital infection, pulmonary infection, acute sinusitis, appendicitis, bloodstream infection, etc.\n5. History of tuberculosis or complications of tuberculosis, or positive\u002Fabnormal findings of clinical significance based on chest X-ray\u002Fchest CT, physical examination, and T-cell interferon-gamma release assay (TIGRA) (e.g., T-Spot or Quanti-FERON®-TB Gold™).\n6. Subjects positive for Hepatitis B (HBsAg, HBeAg, HBeAb, or HBcAb), positive for Hepatitis C antibody, positive for HIV antibody, or positive for syphilis serology.\n\nNOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"70 Years",{"count":297,"type":22},90,[118],"This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.",[301],"Atopic Dermatitis",{"date":282,"type":33},{"date":304,"type":33},"2026-03-31",{"date":230,"type":22},{"name":39,"class":40},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":41},"100622189","phase-1-skb105-for-injection-in-advanced-solid-tumors-100622189","NCT07380386","SKB105 for Injection in Advanced Solid Tumors","A Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB105 for Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants voluntarily joined this study and signed an informed consent form.\n2. The age at the time of signing the informed consent form must be between 18 and 75 years.\n3. Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.\n4. Participants should provide tumor tissue samples for biomarker testing as much as possible during the screening period;\n5. Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.\n6. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.\n7. Expected survival period ≥ 12 weeks.\n8. Participants have sufficient bone marrow, liver, kidney, and coagulation functions.\n9. Male and female participants must agree to use highly effective contraceptive methods during the study period.\n\nExclusion Criteria:\n\n1. Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, and active central nervous system (CNS) metastasis.\n2. Patients with other malignant tumors within 3 years before the first administration.\n3. There are serious heart or vascular diseases or high-risk factors present.\n4. According to researchers' judgment, it is an uncontrollable systemic disease.\n5. There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\\>1 time\u002Fweek).\n6. History of interstitial lung disease or non infectious pneumonia.\n7. There are other lung diseases that may interfere with drug-related pulmonary toxicity.\n8. Severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal diseases that hinder\u002Fdelay corneal healing.\n9. The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.\n10. There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.\n11. Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.\n12. Serious infection occurred within 4 weeks before the first administration.\n13. Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).\n14. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n15. Known active pulmonary tuberculosis.\n16. Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n17. History of allergies to any components of SKB105 injection or severe hypersensitivity reactions to other monoclonal antibodies.\n18. Previously received drug therapy targeting Integrin β6(ITGB6) or any form of drug therapy containing topoisomerase I inhibitors.\n19. Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before the first administration;\n20. Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.\n21. Have undergone major surgical procedures or suffered serious injuries within 28 days prior to the first administration of medication.\n22. Those who have received treatment with other clinical investigational drugs within 28 days prior to their first administration.\n23. Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to their first treatment with the investigational drug.\n24. Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with\\>10 mg\u002Fday prednisone within 2 weeks prior to the first dose.\n25. Within 14 days before the first administration or within 5 half lives of known drugs (whichever is longer), she received a strong inhibitor or strong inducer of cytochrome P450 or a breast cancer resistance protein (BCRP) inhibitor.\n26. Pregnant or lactating women.\n27. Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.\n28. Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.\n29. Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.",{"count":315,"type":22},256,[118,25],"This is a Phase 1\u002F2 clinical study to evaluate the safety and efficacy of SKB105 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.",[121],[320,321],"SKB105","Integrin β6 (ITGB6)",{"date":282,"type":33},{"date":324,"type":33},"2026-03-05",{"date":129,"type":22},{"name":39,"class":40},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":107},"100615993","phase-2-a-study-of-a166-in-patients-with-her2-positive-unresectable-or-metastatic-breast-cancer-100615993","NCT07299825","A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer","Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs","Inclusion Criteria:\n\n1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.\n2. Breast cancer patients by histopathology and\u002For cytology documented.\n3. In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.\n4. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.\n5. At least one measurable lesion according to RECIST 1.1 criteria.\n\nExclusion Criteria:\n\n1. Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.\n2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.\n3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.\n4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.\n5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.\n6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study.",{"count":335,"type":22},40,[25],"Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates",[339],"Her 2 Positive Breast Cancer",{"date":282,"type":33},{"date":342,"type":33},"2024-09-20",{"date":344,"type":22},"2027-12-31",{"name":39,"class":40},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":362,"locationsCount":107},"100615761","phase-2-skb500-combinations-in-patients-with-small-cell-lung-cancer-100615761","NCT07296809","SKB500 Combinations in Patients With Small Cell Lung Cancer","A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female participants between 18 and 75 years old.\n2. Histologically or cytologically confirmed Extensive-stage small cell lung cancer (ES-SCLC):\n\n   * Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.\n   * Cohort 2\\~3: participant has received no prior systemic treatment.\n3. Agree to provide fresh or archival tumor tissue for biomarker analysis.\n4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy \\>= 12 weeks.\n7. Has adequate organ and bone marrow functions.\n8. Has recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.\n9. Effective contraceptive methods should be used during the study and for 6 months after the end of treatment.\n10. Voluntarily join this study, sign the informed consent form, and can comply with the protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.\n2. Has previously received medications with the same target or the same toxins.\n3. Presence of spinal cord compression or clinically active central nervous system metastases.\n4. Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.\n5. Severe infection within 4 weeks or active infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose.\n6. With peripheral neuropathy of grade ≥ 2.\n7. History of any serious, life threatening, or permanently discontinuing adverse events mediated by immunotherapy, including infusion reactions.\n8. Presence of uncontrolled concurrent diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, Severe active peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction, etc.\n9. Serious or uncontrolled heart disease or clinical symptoms requiring treatment.\n10. History of interstitial lung disease (ILD) \u002Fnoninfectious pneumonitis that require steroid treatment, or currently has ILD\u002Fnoninfectious pneumonitis.\n11. Clinical severe lung damage caused by concurrent lung disease.\n12. Uncontrolled hypertension, diabetes, or repeated drainage of pleural effusion\u002Fpericardial effusion\u002F abdominal effusion.\n13. Pregnant or lactating women.\n14. Rapid disease deterioration in the screening process.",{"count":94,"type":22},[25],"The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.",[357],"Small Cell Lung Cancer",{"date":282,"type":33},{"date":360,"type":33},"2026-01-30",{"date":81,"type":22},{"name":39,"class":40},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":107},"100617900","phase-2-sacituzumab-tirumotecan-in-participants-with-locally-advanced-or-metastatic-thymic-carcinoma-100617900","NCT07324629","Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma","A Phase II Clinical Study of Sacituzumab Tirumotecan in Participants With Locally Advanced or Metastatic Thymic Carcinoma With Treatment Failure After Platinum-Based Therapy","Inclusion Criteria:\n\n* Males or females aged ≥ 18 to ≤ 75 years at the time of signing the Informed Consent Form;\n* Participants with histologically or cytologically confirmed thymic carcinoma, and locally advanced or metastatic thymic carcinoma who are not suitable for curative intent therapy;\n* Participants with advanced thymic carcinoma who have progressed after at least one prior platinum-based chemotherapy;\n* Able to provide a tumor tissue sample at the time of or after the diagnosis of locally advanced or metastatic tumor;\n* At least one measurable target lesion that has not received radiotherapy according to RECIST v1.1;\n* ECOG performance status score of 0 or 1;\n* Expected survival ≥ 12 weeks;\n* Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* Participants with histologically or cytologically confirmed thymoma or thymic neuroendocrine tumor;\n* Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and\u002For compression, active or untreated brain metastases;\n* Participants with other malignant tumors within 3 years prior to the first dose;\n* Presence of any of conditions or risk factors related to cardiovascular and cerebrovascular diseases;\n* Uncontrolled systemic disease as judged by the investigator;\n* History of interstitial lung disease\u002Fnoninfectious pneumonitis requiring steroid therapy;\n* Clinically severe pulmonary impairment due to lung disorder;\n* Presence of active hepatitis B or hepatitis C;\n* Known active tuberculosis;\n* Known hypersensitivity to the study drug or any of its components.",{"count":50,"type":22},[25],"The goal of this clinical trial is to learn if drug Sac-TMT works to treat Thymic Carcinoma. It will also learn about the safety of Sac-TMT. The main questions it aims to answer are:\n\n* How effective is drug Sac-TMT in treating Thymic Carcinoma?\n* What adverse events (AEs) do participants have when taking drug Sac-TMT?\n\nParticipants will:\n\n* Progress after at least one platinum-based chemotherapy treatment.\n* Take drug Sac-TMT every 2 weeks.\n* Take tumor response assessments every 6 weeks.",[374],"Thymic Carcinoma",{"date":164,"type":33},{"date":167,"type":22},{"date":378,"type":22},"2028-10",{"name":39,"class":40},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":41},"100598426","phase-3-a-study-of-skb264-versus-investigators-choice-of-chemotherapy-in-subjects-with-unresectable-locally-advanced-relapsed-or-metastatic-hrher2--breast-cancer-who-have-previously-failed-endocrine-therapy-100598426","NCT07071337","A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+\u002FHER2- Breast Cancer Who Have Previously Failed Endocrine Therapy","A Randomized, Open-label, Multicenter Phase III Clinical Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic Hormone Receptor-positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2-negative (HER2-) Breast Cancer Who Have Previously Failed Endocrine Therapy","Inclusion Criteria:\n\n1. Aged ≥ 18 and ≤ 75 years at the time of signing the ICF, male or female;\n2. Histologically and\u002For cytologically confirmed HR+\u002FHER2- BC based on pathological reports from the most recent biopsy or other pathological specimens;\n3. Subjects must have radiologically documented disease progression during or after the most recent treatment prior to enrollment;\n4. No prior systemic chemotherapy for locally advanced, relapsed, or metastatic stages. Subjects who previously received adjuvant\u002Fneoadjuvant chemotherapy and progressed \\>6 months after completion of the last chemotherapy treatment will be allowed for study inclusion;\n5. The investigator assessed that the patient could not continue to benefit from endocrine therapy and was suitable for receiving first-line chemotherapy;\n6. Able to provide recently newly obtained or archival tumor tissue sections at or after diagnosis of relapsed or metastatic tumor within the recent prior to randomization;\n7. At least one measurable lesion per RECIST v1.1；\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;\n9. Life expectancy of ≥ 12 weeks;\n10. Suitable to receive one of the chemotherapy regimens listed in the investigator's choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine) as assessed by the investigator;\n11. Adequate organ and bone marrow function;\n12. Having recovered from all toxicities due to prior treatment;\n13. Use of effective medical contraception during study treatment and for 6 months after the end of dosing for female subjects of childbearing potential and male subjects with partners of childbearing potential;\n14. Willingness to participate in the study, sign the ICF, and comply with the protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n1. Subjects with locally advanced breast cancer suitable for curative therapy at study enrollment;\n2. Other malignancies (except those tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to randomization;\n3. Subiects with known meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression or active centralnervous system (CNS) metastases.\n4. Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors;\n5. History of (noninfectious) interstitial lung disease (ILD)\u002Fnoninfectious pneumonitis requiring steroid therapy and current ILD\u002Fnoninfectious pneumonitis, or suspected ILD\u002Fnoninfectious pneumonitis at screening that cannot be excluded by imaging;\n6. Clinically serious lung injuries caused by lung diseases;\n7. Serious infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;\n8. Documented severe dry eye syndrome, severe meibomian gland dysfunction and\u002For blepharitis, or history of severe corneal disorders that prevent\u002Fdelay corneal healing;\n9. History of esophagogastric varices, severe ulcers, gastric perforation, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to randomization;\n10. Active hepatitis B (hepatitis B surface antigen positive and HBV-DNA ≥ 500 IU\u002FmL or above the ULN, whichever is higher) or hepatitis C (hepatitis C antibody positive and HCV-RNA above the ULN);\n11. Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n12. 12 Known hypersensitivity to SKB264 or investigator's choice chemotherapy or any of its excipients, including but not limited to polysorbate-20, or history of severe hypersensitivity reaction to other monoclonal antibodies;\n13. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n14. Pregnant or lactating women;\n15. Prior TROP2-targeted therapy or any treatment containing chemotherapeutic agents targeting topoisomerase I (including antibody-drug conjugates \\[ADCs\\]);\n16. Live vaccines within 4 weeks prior to randomization or scheduled to receive live vaccines during study treatment;\n17. Receipt of the following therapies prior to randomization: a)Major surgery within 4 weeks prior or expected major surgery during the study; b)Radiation therapy within 2 weeks prior (extensive radiation therapy including radiopharmaceuticals within 4 weeks prior); c)Any immunotherapy, biological therapy, or other investigational drugs within 4 weeks or 5 half-lives of prior drug use (whichever is shorter) (bisphosphonates or RANK-L inhibitors for bone metastases are permitted prior to randomization); or traditional Chinese medicine with approved anti-tumor indications, small molecule targeted therapy, or endocrine therapy within 2 weeks prior.\n18. Rapid deterioration of the condition, e.g., significant changes in performance status, etc., during the screening process.",{"count":388,"type":22},430,[390],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+\u002FHER2- breast cancer who have previously failed endocrine therapy.",[393],"Metastatic Breast Cancer",[395,396],"SKB264","HR+\u002FHER2- breast cancer",{"date":282,"type":33},{"date":399,"type":33},"2025-07-18",{"date":401,"type":22},"2031-02",{"name":39,"class":40},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":107},"100599646","phase-1-a-study-of-skb107-in-advanced-solid-tumors-with-bone-metastases-100599646","NCT07087197","A Study of SKB107 in Advanced Solid Tumors With Bone Metastases","A Multicenter, Open-label Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of SKB107 in Subjects With Advanced Solid Tumors With Bone Metastases","Inclusion Criteria:\n\n1. The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);\n2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;\n3. The expected survival period should be ≥ 3 months;\n4. Phase Ia: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment;\n5. Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;\n6. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least one site was confirmed by CT or MRI;\n7. Have adequate organ and bone marrow functions;\n8. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;\n9. The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.\n\nExclusion Criteria:\n\n1. The washout period before the first administration of the study drug was insufficient.\n2. Previous received similar radionuclide internal irradiation treatment.\n3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.\n4. Known \"super bone imaging\".\n5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.\n6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.\n7. Poorly controlled diabetes and hypertension.\n8. The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion\u002Fexclusion criteria.\n9. Had other malignant tumors within 3 years before the first administration.\n10. Subjects with severe and\u002For uncontrolled concomitant diseases.\n11. Active hepatitis B or active hepatitis C.\n12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.\n13. Subjects with a history of radionuclide\u002Fradioactive drug allergy, or allergic to any component of the study formulation.\n14. During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.\n15. Subjects participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an intervention study.\n16. Any unstable disease or clinical condition, or any condition that may endanger the safety of the subject or affect the subject's compliance, or any other conditions that the investigator deems inappropriate for participation in this study.",{"count":297,"type":22},[118],"A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases.",[414],"Metastatic Solid Tumors",{"date":282,"type":33},{"date":417,"type":33},"2025-08-15",{"date":419,"type":22},"2028-07-01",{"name":39,"class":40},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":440},"100594456","phase-2-a-study-of-skb518-in-patients-with-lung-cancer-100594456","NCT07019675","A Study of SKB518 in Patients With Lung Cancer","A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer","Inclusion Criteria:\n\n1. Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.\n2. Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.\n3. At least one measurable tumor lesion per RECIST v1.1.\n4. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n5. Expected survival period ≥ 12 weeks.\n6. The function of important organs meets the requirements of the protocol.\n\nExclusion Criteria:\n\n1. Symptomatic or uncontrolled cardiovascular disease\n2. History of noninfectious pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD;\n3. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \\>10 mg\u002Fd) or other immunosuppressive therapy within 14 days before the first dose.\n4. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n5. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.",{"count":429,"type":22},192,[25],"This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.",[433],"Lung Carcinoma",{"date":282,"type":33},{"date":436,"type":33},"2025-08-29",{"date":438,"type":22},"2027-10-20",{"name":39,"class":40},17,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":458,"locationsCount":107},"100579572","phase-1-skb445-for-injection-in-solid-tumors-100579572","NCT06826040","SKB445 for Injection in Solid Tumors","A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. At the time of signing the ICF: age between 18 -75 years, male or female.\n2. subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed\u002Fare intolerant\u002Fineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n4. Expected survival ≥ 3 months.\n5. Subjects with adequate organ and bone marrow function confirmed by laboratory results\n6. Subjects of childbearing potential (male or female) must use effective medical contraception during the study\n7. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.\n\nExclusion Criteria:\n\n1. Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).\n2. Has had major surgery within 4 weeks prior to the first dose.\n3. Has known history of allergy to any component of SKB445 or SKB445.\n4. Has a known previous or concurrent other malignancies within 3 years prior to first dose.\n5. Presence of active central nervous system (CNS) metastases.\n6. Has uncontrolled or severe cardiovascular disease.\n7. Has uncontrolled systemic diseases.\n8. Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.\n9. Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.\n10. Has prior autologous\u002Fallogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n11. Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.",{"count":449,"type":22},126,[118],"This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.",[121],[121],{"date":282,"type":33},{"date":456,"type":33},"2025-02-05",{"date":344,"type":22},{"name":39,"class":40},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":107},"100572673","phase-1-a-study-on-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-skb500-in-subjects-with-advanced-solid-tumors-100572673","NCT06736327","A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors","A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 for Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants between 18 and 75 years old.\n2. Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.\n3. Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.\n4. Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1\n5. ECOG performance status score of 0 or 1.\n6. Expected survival of at least 12 weeks.\n7. Has adequate hematopoietic, renal and hepatic functions.\n8. Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.\n9. Male and female subjects must agree to use highly effective contraceptive methods throughout the study.\n10. Subjects must voluntarily enter the study, sign the informed consent form, and be able to comply with the visits and procedures.\n\nExclusion Criteria:\n\n1. Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.\n2. Subjects with other malignancies within 5 years before the first dose.\n3. Any severe and\u002For uncontrolled concurrent disease that may interfere with the subject's participation in the study.\n4. Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).\n5. History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.\n6. Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.\n7. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n8. Uncontrolled pleural effusion, ascites, or pericardial effusion.\n9. Have received ADCs with the same target or the same toxins.\n10. Have received chemotherapy, small molecule targeted therapy, and traditional Chinese medicine preparations within 14 days or 5 half-lives before the first dose; have received any immunotherapy, large molecule anticancer drug treatment, or more than 30% bone marrow radiation or extensive radiotherapy within 28 days before the first dose.\n11. Have undergone major surgery or severe trauma within 28 days before the first dose.\n12. Have received other clinical trial medications within 28 days before the first dose.\n13. Has previously received anti-cancer or live vaccines within 28 days before the first dose\n14. Have received systemic steroids or other immunosuppressive treatments within 14 days before the first dose.\n15. Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 days or 5 half-lives before the first dose.\n16. Pregnant or lactating female.\n17. Any disease or condition that, in the investigator's opinion, would compromise subject safety or interfere with study assessments.",{"count":276,"type":22},[118],"This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.",[121],{"date":282,"type":33},{"date":472,"type":33},"2024-12-13",{"date":61,"type":22},{"name":39,"class":40},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":494},"100571832","phase-1-a-phase-1-study-of-skb571-in-subjects-with-advanced-solid-tumors-100571832","NCT06725381","A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors","A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects aged 18-75 years at the time of signing the informed consent form\n2. Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors .\n3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.\n4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1.\n5. Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months.\n6. Subjects who have adequate organ function.\n7. Subjects who have recovered from all toxicities due to prior therapy .\n8. Male and female subjects must agree to use highly effective contraception methods during the study treatment.\n9. Subjects who voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with known active or untreated central nervous system (CNS) metastases.\n2. Subjects with other malignant tumors within 3 years prior to the first dose.\n3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease.\n4. Subjects with known active pulmonary tuberculosis.\n5. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C.\n6. Subjects with major surgery within 28 days prior to the first dose.\n7. Subjects with known allergy or hypersensitivity to SKB571 or its excipients.\n8. Subjects with clinically severe lung injuries due to pulmonary complications.\n9. Subjects with a history of allogeneic tissue\u002Fsolid organ transplant.\n10. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage.\n11. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study.\n12. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer.\n13. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment.\n14. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment.\n15. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \\> 10 mg\u002Fd or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment.\n16. Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571.\n17. Subjects whose condition deteriorates rapidly before the first dose, such as a severe physical impariment or a change in ECOG score no longer meeting the inclusion criteria.\n18. Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study.\n19. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.",{"count":483,"type":22},138,[118],"This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .",[487],"Solid Malignancies",{"date":282,"type":33},{"date":490,"type":33},"2024-12-17",{"date":492,"type":22},"2027-12",{"name":39,"class":40},15,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":514,"locationsCount":515},"100571908","phase-1-a-phase-1-study-to-evaluate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-mk-6204-skb535-for-injection-in-participants-with-advanced-solid-tumors-100571908","NCT06726369","A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Have a histologically or cytologically confirmed advanced\u002Fmetastatic solid tumor by pathology report and have failed or do not have available standard treatments. The tumor types will be limited to: CRC; Gastric carcinoma or gastroesophageal junction (GEJ) adenocarcinoma; Esophageal carcinoma; Pancreatic cancer; NSCLC; Cervical carcinoma; Head and Neck squamous cell carcinoma.\n3. Have measurable disease by RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Target lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n4. Have a performance status of 0 or 1 on the ECOG Performance Scale.\n5. The participant has provided documented informed consent for the study.\n6. Participants who agree to provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.\n7. Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n\nExclusion Criteria:\n\n1. Active severe digestive disease, including but not limited to complete or incomplete gastric outlet obstruction, persistent\u002Frecurrent vomiting, severe gastrointestinal hemorrhage, gastric or duodenal ulcers, acute gastrointestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon, or Crohn's disease.\n2. Participants with a history of interstitial lung disease (ILD) or a history of noninfectious pneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n3. Received strong cytochrome P450 (CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.\n4. Received strong breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose of study intervention or within 5 half-lives of drug elimination, whichever is longer.\n5. Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before intervention allocation.\n6. Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n7. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.",{"count":297,"type":22},[118],"This is an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors.",[121],[506,507,508,509],"ADC","safety","tolerability","pharmacokinetics",{"date":164,"type":33},{"date":512,"type":33},"2024-12-12",{"date":81,"type":22},{"name":39,"class":40},7,""]