[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":20,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":20,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":20},{"fullName":5,"class":6},"Ganzhou Hemay Pharmaceutical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Intravenous infusion, Once per treatment cycle",[13],"Drug: Hemay5087",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Hemay5087","intravenous infusion，once every 3 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"jingyi xu","CONTACT","86-022-24899621","xujingyi@hemay.com.cn",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100640733",false,"NCT07624864","A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors","A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS","Inclusion Criteria:\n\n1. Subjects who voluntarily signed a written informed consent form before the start of the study;\n2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .\n3. Subjects who have a least one measurable lesion that can be evaluated by CT\u002FMRI and meets the requirement for reproducible evaluation in RECIST V1.1;\n4. At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and\u002For major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0) \\[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\\];\n5. Subjects with ECOG PS score of 0-1;\n6. Subjects with expected survival more than 3 months;\n7. Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;\n\nExclusion Criteria:\n\n1. Women during pregnancy or breastfeeding;\n2. Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA \\> ULN;;\n3. Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;\n4. Aallergy to the active ingredient or excipients of the investigational medicinal product;\n5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;\n6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.","ALL","18 Years","75 Years",{"count":39,"type":40},24,"ESTIMATED","INTERVENTIONAL",[43],"PHASE1","An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.",[46],"Solid Tumors","NOT_YET_RECRUITING","2026-05-29",{"date":50,"type":51},"2026-06-03","ACTUAL",{"date":53,"type":40},"2026-07-15",{"date":55,"type":40},"2028-06-30",{"name":5,"class":6}]