[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587375":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-20122","EXPERIMENTAL","All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage",[13],"Drug: HS-20122",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Intravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Ketao Chen","CONTACT","18795500836","chenkt@hspharm.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":19,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Ethics Committee of Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":35,"coordinates":36},"Point",[37,38],113.25,23.11667,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Xuzhi Pan","020-87343009","llwyh@sysucc.org.cn",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100587375","phase-1-a-study-of-hs-20122-in-patients-with-advanced-solid-tumors-100587375",false,"NCT06927570","A Study of HS-20122 in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors\n* Standard treatment is invalid, unavailable or intolerable.\n* At least 1 target lesion according to RECIST 1.1.\n* ECOG PS score: 0-1.\n* Estimated Life expectancy\\> 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Women must have the evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Evidence of cardiovascular risk.\n* Subjects with severe or poorly controlled diabetes.\n* Subjects with severe or poorly controlled hypertension.\n* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Subjects with severe arteriovenous thrombotic events within 3 months.\n* Subjects with severe infection within 4 weeks prior to the first dose.\n* Subjects who have received steroid therapy for more than 30 days .\n* Presence of known active infectious diseases.\n* Presence of clinically significant gastrointestinal dysfunction.\n* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Hypersensitivity to any ingredient of HS-20122.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Evidence of cardiovascular risk.\n* Subjects with severe or poorly controlled diabetes.\n* Subjects with severe or poorly controlled hypertension.\n* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Subjects with severe arteriovenous thrombotic events within 3 months.\n* Subjects with severe infection within 4 weeks prior to the first dose.\n* Subjects who have received steroid therapy for more than 30 days .\n* Presence of known active infectious diseases.\n* Presence of clinically significant gastrointestinal dysfunction.\n* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Hypersensitivity to any ingredient of HS-20122.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments","ALL","18 Years",{"count":57,"type":58},1050,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.",[64],"Advanced Solid Tumors",[64,9],"2026-01-15",{"date":68,"type":69},"2026-01-16","ACTUAL",{"date":71,"type":69},"2025-04-15",{"date":73,"type":58},"2028-06-30",{"name":5,"class":6},1]