[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553543":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":27,"responsibleParty":100,"collaborators":11,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":11,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":11,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Shanghai Pharmaceuticals Holding Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SPH7485","EXPERIMENTAL",null,[13],"Drug: SPH7485",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","SPH7485： Orally, once daily, 50-400mg, 21 days per cycle",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Xiaohua Wu","CONTACT","0086-021-34778299","shanboer@126.com",{"name":26,"role":22,"phone":11,"phoneExt":11,"email":11},"Jian Zhang",[28,45,56,67,78,89],{"facility":29,"status":30,"city":31,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"XiangYa Hospital CentralSouth University","RECRUITING","Changsha","China","CN",{"type":35,"coordinates":36},"Point",[37,38],112.97087,28.19874,{"lat":38,"lon":37},[41,43],{"name":42,"role":22,"phone":11,"phoneExt":11,"email":11},"Yan Tian",{"name":44,"role":22,"phone":11,"phoneExt":11,"email":11},"Dai Li",{"facility":46,"status":30,"city":47,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Fujian Cancer Hospital","Fuzhou",{"type":35,"coordinates":49},[50,51],119.30611,26.06139,{"lat":51,"lon":50},[54],{"name":55,"role":22,"phone":11,"phoneExt":11,"email":11},"An Lin",{"facility":57,"status":30,"city":58,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Zhejiang Cancer Hospital","Hangzhou",{"type":35,"coordinates":60},[61,62],120.16142,30.29365,{"lat":62,"lon":61},[65],{"name":66,"role":22,"phone":11,"phoneExt":11,"email":11},"Jianqing Zhu",{"facility":68,"status":30,"city":69,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Yunnan Cancer Hospital","Kunming",{"type":35,"coordinates":71},[72,73],102.71833,25.03889,{"lat":73,"lon":72},[76],{"name":77,"role":22,"phone":11,"phoneExt":11,"email":11},"Hongying Yang",{"facility":79,"status":30,"city":80,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Fudan University Shanghai Cancer Center","Shanghai",{"type":35,"coordinates":82},[83,84],121.45806,31.22222,{"lat":84,"lon":83},[87,88],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":11},{"name":26,"role":22,"phone":11,"phoneExt":11,"email":11},{"facility":90,"status":30,"city":91,"state":11,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan",{"type":35,"coordinates":93},[94,95],114.26667,30.58333,{"lat":95,"lon":94},[98],{"name":99,"role":22,"phone":11,"phoneExt":11,"email":11},"Guiling Li",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100553543","phase-1-a-clinical-study-of-sph7485-tablets-in-the-treatment-of-advanced-solid-tumors-100553543",false,"NCT06487455","A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.","An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced solid tumors；\n2. At least one extracranial measurable lesion;\n3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;\n4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;\n5. Life expectancy≥3 months;\n6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;\n7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;\n8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.\n\nExclusion Criteria:\n\n1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;\n2. Subjects who have received previous drugs with the same target;\n3. Subjects with active infections requiring systemic treatment;\n4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;\n5. Subjects with uncontrolled or severe cardiovascular disease;\n6. Severe lung disease;\n7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;\n8. Subjects taking strong\u002Fmoderate inhibitors or inducers of CYP3A4;\n9. Subjects who use or require long-term use of hormonotherapy before screening;\n10. Subjects who have had other malignancies within the past 5 years;\n11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;\n12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;\n13. Abnormal virological examination during screening; History of immune deficiency;\n14. Uncontrolled systemic diseases;\n15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;\n16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;\n17. Subjects with a history of severe allergy or known allergy to this product and its excipients;\n18. Subjects who cannot follow the study protocol to complete the required study visit and dosing;\n19. Subjects with a history of alcohol or drug abuse;\n20. Lactating female patients;\n21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;\n22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.","ALL","18 Years","75 Years",{"count":113,"type":114},170,"ESTIMATED","INTERVENTIONAL",[117],"PHASE1","To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.",[120],"Advanced Solid Tumor","2025-08-15",{"date":123,"type":124},"2025-08-17","ACTUAL",{"date":126,"type":124},"2024-08-06",{"date":128,"type":114},"2027-12-31",{"name":5,"class":6},6]