[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575218":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":49,"centralContacts":68,"locations":74,"responsibleParty":94,"collaborators":49,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":49,"enrollmentInfo":106,"targetDuration":49,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":77,"whyStopped":49,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19,24,29,34,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Advanced prostate cancer",[13],"Drug: HS-10502 + NHA",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Advanced prostate cancer or solid tumor",[18],"Drug: HS-10502 + HS-20093",{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3","Advanced HER2-negative breast cancer or recurrent ovarian cancer",[23],"Drug: HS-10502+ Apatinib",{"label":25,"type":10,"description":26,"interventionNames":27},"Cohort 4","Recurrent ovarian cancer",[28],"Drug: HS-10502 + HS-20089",{"label":30,"type":10,"description":31,"interventionNames":32},"Cohort 5","Platinum-sensitive recurrent ovarian cancer",[33],"Drug: HS-10502 + Platinum + Bevacizumab",{"label":35,"type":10,"description":36,"interventionNames":37},"Cohort 6","Advanced gastric cancer or solid tumor",[38],"Drug: HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan",{"label":40,"type":10,"description":41,"interventionNames":42},"Cohort 7","HRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer",[43],"Drug: HS-10502 + Bevacizumab",[45,50,53,56,59,62,65],{"type":46,"name":47,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","HS-10502 + NHA",[9],null,{"type":46,"name":51,"description":51,"armGroupLabels":52,"otherNames":49},"HS-10502 + HS-20093",[15],{"type":46,"name":54,"description":54,"armGroupLabels":55,"otherNames":49},"HS-10502+ Apatinib",[20],{"type":46,"name":57,"description":57,"armGroupLabels":58,"otherNames":49},"HS-10502 + HS-20089",[25],{"type":46,"name":60,"description":60,"armGroupLabels":61,"otherNames":49},"HS-10502 + Platinum + Bevacizumab",[30],{"type":46,"name":63,"description":63,"armGroupLabels":64,"otherNames":49},"HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan",[35],{"type":46,"name":66,"description":66,"armGroupLabels":67,"otherNames":49},"HS-10502 + Bevacizumab",[40],[69],{"name":70,"role":71,"phone":72,"phoneExt":49,"email":73},"Xi Yan","CONTACT","18721195312","yanx1@hspharm.com",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":84,"coordinates":85},"Point",[86,87],121.45806,31.22222,{"lat":87,"lon":86},[90],{"name":91,"role":71,"phone":92,"phoneExt":49,"email":93},"Ding Wei Ye","13701663571","fuscc2012@163.com",{"type":95,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100575218","phase-1-hs-10502-combination-treatment-in-patients-with-advanced-solid-tumors-100575218",false,"NCT06769425","HS-10502 Combination Treatment in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors","HS-10502","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Patients diagnosed with pathologically confirmed advanced solid tumors.\n* Subjects have at least one target lesion as assessed per the RECIST 1.1.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n* Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n* Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n* Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received or is currently receiving the following treatment: PARPi\u002FB7-H4\u002FB7-H3-targeted therapies;\n* Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.\n* Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n* Known history of other primary malignancy.\n* Evidence of brain metastasis and\u002For cancerous meningitis\n* Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n* Cardiological examination abnormality.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious or poorly controlled diabetes.\n* Serious or poorly controlled hypertension.\n* Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n* Serious infections within 4 weeks prior to the first dose.\n* Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n* Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n* Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n* Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* History of severe neurological or psychiatric disorder.\n* Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n* Attenuated live vaccination within 4 weeks prior to the first dose.\n* Subjects with autoimmune disease that is active or is likely to recur.\n* Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms\u002Fsigns of intestinal obstruction within 6 months prior to the first dose of study drug.\n* Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n* Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.","ALL","18 Years",{"count":107,"type":108},157,"ESTIMATED","INTERVENTIONAL",[111],"PHASE1","HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.",[114,115,116,117,118,119],"Recurrent Ovarian Cancer","HER2-negative","Advanced Breast Cancer","TNBC","Advanced Prostate Cancer","Advanced Gastric Cancer",[121,102,122,123,117,124,125],"Poly(ADP-ribose) polymerase-1 inhibitor","ovarian cancer","breast cancer","prostate cancer","gastric cancer","2025-06-18",{"date":128,"type":129},"2025-06-24","ACTUAL",{"date":131,"type":129},"2025-05-07",{"date":133,"type":108},"2026-08-31",{"name":5,"class":6},1]