[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623054":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":19,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"JSKN027","EXPERIMENTAL","Participants will receive JSKN027 administered by intravenous infusion at dose levels based on actual body weight (mg\u002Fkg). The planned dose levels are 1, 3, 6, 10, 15, and 20 mg\u002Fkg, administered once every 3 weeks (Q3W).",[13],"Drug: JSKN027",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","JSKN027 is an investigational therapeutic agent being evaluated for the treatment of advanced malignant solid tumors. It is administered as intravenous monotherapy at multiple dose levels in this study.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Clinical Trial Enrollment Contact","CONTACT","+86-1 5 2 0 1 3 9 3 1 2 0","ruiliu@alphamabonc.com",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Peking University Cancer Hospital","Beijing","Beijing Municipality","100142","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Lin Shen, MD","+86-10-88121122","shenlin@bjmu.edu.cn",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100623054","phase-1-a-study-of-jskn027-in-patients-with-advanced-solid-tumors-100623054",false,"NCT07391644","A Study of JSKN027 in Patients With Advanced Solid Tumors","A First-in-Human, Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of JSKN027 in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing the ICF.\n* ECOG performance status 0-1.\n* Estimated life expectancy ≥ 3 months.\n* Histologically or cytologically confirmed advanced or metastatic malignant solid tumor.\n* For dose escalation (Part Ia): disease has progressed on standard therapy.\n* For dose expansion (Part Ib): participants with prespecified tumor types (e.g., colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and other selected solid tumors) who have progressed on standard therapy.\n* At least one measurable extracranial lesion per RECIST v1.1.\n* Adequate bone marrow function within 7 days prior to enrollment (e.g., ANC ≥ 1.5×10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100×10\\^9\u002FL).\n* Adequate hepatic function within 7 days prior to enrollment (e.g., total bilirubin, AST\u002FALT, ALP within protocol-defined limits; albumin ≥ 30 g\u002FL).\n* Adequate renal function within 7 days prior to enrollment (e.g., serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 60 mL\u002Fmin; urine protein within acceptable limits).\n* Adequate coagulation function within 7 days prior to enrollment (e.g., PT\u002FINR and aPTT within protocol-defined limits).\n* Adequate cardiac function (e.g., LVEF ≥ 50%).\n* Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.\n* Participants of reproductive potential agree to use highly effective contraception from ICF signing until 7 months after the last dose.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease (e.g., active brain metastases or leptomeningeal disease).\n* Received an investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to first dose.\n* Major surgery within 28 days prior to first dose or planned major surgery during the study.\n* History of severe immune-related adverse events or prior toxicity that would preclude safe participation, as judged by the investigator.\n* Significant gastrointestinal disorders that increase risk of perforation, bleeding, obstruction, or interfere with study participation.\n* Active or uncontrolled interstitial lung disease (ILD) or non-infectious pneumonitis, or suspected ILD\u002Fpneumonitis at screening.\n* Active autoimmune disease requiring systemic immunosuppression (exceptions may apply for limited, stable conditions).\n* Active hepatitis B or C, HIV infection, or other clinically significant immunodeficiency\u002Finfection not adequately controlled per local standards.\n* Prior allogeneic organ or bone marrow transplant.\n* Known hypersensitivity to the study drug or its excipients, or history of severe hypersensitivity to similar biologic agents.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would compromise participant safety or compliance.","ALL","18 Years",{"count":57,"type":58},250,"ESTIMATED","INTERVENTIONAL",[61],"PHASE1","This is a first-in-human, open-label, multicenter Phase 1 (Ia\u002FIb) clinical study conducted in China to evaluate the safety and tolerability of JSKN027 in patients with advanced malignant solid tumors. The study will also assess the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of JSKN027, and determine the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D).\n\nThe study includes two parts. Part Ia is a dose-escalation phase designed to evaluate the safety and tolerability of increasing dose levels of JSKN027. Part Ib is a dose-expansion phase in which additional patients will be enrolled at selected dose levels to further evaluate safety and preliminary antitumor activity in specific tumor types. Initial expansion cohorts are planned for patients with colorectal cancer, non-small cell lung cancer, and hepatocellular carcinoma.",[64],"Advanced Malignant Solid Tumor","NOT_YET_RECRUITING","2026-01-30",{"date":68,"type":69},"2026-02-06","ACTUAL",{"date":71,"type":58},"2026-03-15",{"date":73,"type":58},"2029-06-30",{"name":5,"class":6},1]