[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658122":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":60,"studyPopulation":60,"armGroups":67,"interventions":74,"overallOfficials":60,"centralContacts":79,"locations":85,"responsibleParty":138,"collaborators":60,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":60,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":60,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":60,"overallStatus":159,"whyStopped":60,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Akeso","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":60},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with dose limiting toxicities (DLTs)","DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.","During the first 3 weeks of treatment.",{"measure":14,"description":15,"timeFrame":16},"Number of participants with adverse events (AEs)","AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.","From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.",[18,22,25,28,31,34,37,41,45,48,51,54,57],{"measure":19,"description":20,"timeFrame":21},"Area under curve (AUC)","The area under the curve of the drug concentration in the blood over time","From pre-dose to the end of the last dose, an average of 6 months.",{"measure":23,"description":24,"timeFrame":21},"Maximum Concentration (Cmax)","The peak value of the plasma drug concentration reached on the time curve after a single administration",{"measure":26,"description":27,"timeFrame":21},"Peak Time (Tmax)","The time required for the drug concentration in human plasma to reach its peak (peak concentration) after administration",{"measure":29,"description":30,"timeFrame":21},"The terminal elimination half-life (t1\u002F2)","The time that takes for the elimination processes to reduce the plasma concentration of the drug in the body by 50%",{"measure":32,"description":33,"timeFrame":21},"Clearance (CL)","The ability of the kidneys to completely eliminate a certain substance from the plasma within a unit of time",{"measure":35,"description":36,"timeFrame":21},"Volume of distribution (V)","The total volume of body fluid required for a drug, calculated based on the blood drug concentration in a dynamic equilibrium state",{"measure":38,"description":39,"timeFrame":40},"Anti-drug antibodies (ADA)","The number and percentage of participants with detectable anti-drug antibodies (ADA)","From pre-dose to 30 days post end of treatment",{"measure":42,"description":43,"timeFrame":44},"Objective Response Rate (ORR) assessed by investigator per RECIST v1.1","ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.","Up to approximately 2 years",{"measure":46,"description":47,"timeFrame":44},"Disease Control Rate (DCR) assessed per RECIST v1.1","DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1.",{"measure":49,"description":50,"timeFrame":44},"Duration of response (DoR) assessed by the investigator per RECIST v1.1","DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.",{"measure":52,"description":53,"timeFrame":44},"Time to response (TTR) assessed by the investigator per RECIST v1.1","TTR is defined as the time to objective response based on RECIST v1.1.",{"measure":55,"description":56,"timeFrame":44},"Progression Free Survival (PFS) assessed by investigator per RECIST v1.1","PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.",{"measure":58,"description":59,"timeFrame":44},"Overall survival (OS)","OS is defined as the time from the first dose to death from any cause.",null,{"allocation":62,"interventionModel":63,"interventionModelDescription":60,"primaryPurpose":64,"observationalModel":60,"timePerspective":60,"maskingInfo":65},"NA","SEQUENTIAL","TREATMENT",{"masking":66,"maskingDescription":60,"whoMasked":60},"NONE",[68],{"label":69,"type":70,"description":71,"interventionNames":72},"AK157D1 for injection","EXPERIMENTAL","AK157D1 for injection will be administered in prespecified dose levels",[73],"Drug: AK157D1 for injection",[75],{"type":76,"name":69,"description":77,"armGroupLabels":78,"otherNames":60},"DRUG","IV infusion, administered on Day 1 of each cycle, Q3W, continuous treatment",[69],[80],{"name":81,"role":82,"phone":83,"phoneExt":60,"email":84},"Zhifang Yao, M.D.","CONTACT","+86-0760-89873999","clinicaltrails@akesobio.com",[86,104,119],{"facility":87,"status":60,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang","150081","China","CN",{"type":94,"coordinates":95},"Point",[96,97],126.65,45.75,{"lat":97,"lon":96},[100],{"name":101,"role":82,"phone":102,"phoneExt":60,"email":103},"Tongsen Zheng, M.D.","+86-15134569619","ztsgcp@126.com",{"facility":105,"status":60,"city":106,"state":107,"zip":108,"country":91,"countryCode":92,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Shanghai Pulmonary Hospital","Shanghai","Shanghai Municipality","200433",{"type":94,"coordinates":110},[111,112],121.45806,31.22222,{"lat":112,"lon":111},[115],{"name":116,"role":82,"phone":117,"phoneExt":60,"email":118},"Shengxiang Ren, M.D.","+86-13816756732","harry_ren@126.com",{"facility":120,"status":60,"city":121,"state":122,"zip":123,"country":91,"countryCode":92,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"West China Hospital of Sichuan University","Chengdu","Sichuan","610044",{"type":94,"coordinates":125},[126,127],104.06667,30.66667,{"lat":127,"lon":126},[130,134],{"name":131,"role":82,"phone":132,"phoneExt":60,"email":133},"Jianxin Xue, M.D.","+86-18982251798","killercell@163.com",{"name":135,"role":82,"phone":136,"phoneExt":60,"email":137},"Li Zheng, M.D.","+86-18980601950","lzheng2005618@163.com",{"type":139,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100658122","phase-1-a-study-of-ak157d1-for-injection-in-advanced-solid-tumors-100658122",false,"NCT07847281","A Study of AK157D1 for Injection in Advanced Solid Tumors","A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK157D1 in the Treatment of Advanced Solid Tumors Conditions","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.\n4. At least one measurable lesion according to RECIST v1.1.\n5. ECOG PS 0 or 1.\n6. The expected lifespan is ≥3 months.\n7. Have sufficient organ function.\n8. Females participants must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.\n\nExclusion Criteria:\n\n1. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n2. Having other active malignancies within 3 years.\n3. Having received major surgical operations within 4 weeks before the first administration.\n4. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.\n5. Participants with a history of mental illness and incapacitated or limited capacity.\n6. Having received systemic anti-tumor treatment within 3 weeks.\n7. Having received any treatment targeting B7H3.\n8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n9. Previous history of severe hypersensitivity reactions.\n10. Participants with active autoimmune diseases requiring systemic treatment within 2 years.\n11. Known to be positive for HIV and other infections.\n12. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.\n13. Live attenuated vaccines were received within 4 weeks.\n14. Currently participating in another interventional clinical study.\n15. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.","ALL","18 Years","75 Years",{"count":151,"type":152},243,"ESTIMATED","INTERVENTIONAL",[155],"PHASE1","This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors.",[158],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-09-28",{"date":162,"type":163},"2026-09-29","ACTUAL",{"date":165,"type":152},"2026-09-21",{"date":167,"type":152},"2029-09-15",{"name":5,"class":6},3]