[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498151":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":22,"armGroups":50,"interventions":57,"overallOfficials":22,"centralContacts":63,"locations":69,"responsibleParty":88,"collaborators":22,"id":90,"slug":22,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":22,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":22,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":22,"overallStatus":108,"whyStopped":22,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Xuanzhu Biopharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":22},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD) of KM602, if any","Determined by the frequency of dose-limiting toxicities during dose-escalation","Approximately 15 months",{"measure":14,"description":11,"timeFrame":12},"Recommended Phase 2 dose (RP2D) of KM602",{"measure":16,"description":17,"timeFrame":18},"Incidence of treatment emergent adverse events","Severity graded per CTCAE version 5.0","Through study completion, approximately 28 months",[20,23,25,27,29,31,33,35,37,39,41],{"measure":21,"description":22,"timeFrame":18},"Maximum Plasma Concentration (Cmax) of KM602",null,{"measure":24,"description":22,"timeFrame":18},"Area Under the Curve (AUC) of KM602",{"measure":26,"description":22,"timeFrame":18},"t1\u002F2 of KM602",{"measure":28,"description":22,"timeFrame":18},"Plasma clearance (CL) of KM602",{"measure":30,"description":22,"timeFrame":18},"Volume of distribution (V) of KM602",{"measure":32,"description":22,"timeFrame":18},"Anti-Drug Antibody of KM602",{"measure":34,"description":22,"timeFrame":18},"Objective Response Rate (ORR) of KM602",{"measure":36,"description":22,"timeFrame":18},"Disease Control Rate (DCR) of KM602",{"measure":38,"description":22,"timeFrame":18},"Progression-free survival(PFS) of KM602",{"measure":40,"description":22,"timeFrame":18},"Duration of Response (DOR) of KM602",{"measure":42,"description":22,"timeFrame":18},"Overall survival (OS) of KM602",{"allocation":44,"interventionModel":45,"interventionModelDescription":22,"primaryPurpose":46,"observationalModel":22,"timePerspective":22,"maskingInfo":47},"NA","SINGLE_GROUP","TREATMENT",{"masking":48,"maskingDescription":22,"whoMasked":22},"NONE","This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"KM602 monotherapy","EXPERIMENTAL","Dose escalation and expansion",[56],"Biological: KM602",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":22},"BIOLOGICAL","KM602","Multiple dose levels of KM602 will be administered, including 0.01 mg\u002Fkg QW, 0.1 mg\u002Fkg QW, 0.6 mg\u002Fkg QW, 3 mg\u002Fkg QW, and 10 mg\u002Fkg QW. KM602 is administered intravenously once a week, and each cycle is 21 days.",[52],[64],{"name":65,"role":66,"phone":67,"phoneExt":22,"email":68},"Xingming Fan","CONTACT","086-18513114991","fanxingming@xuanzhubio.com",[70],{"facility":71,"status":22,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Beijing Cancer Hospital","Beijing","Beijing Municipality","100142","China","CN",{"type":78,"coordinates":79},"Point",[80,81],116.39723,39.9075,{"lat":81,"lon":80},[84],{"name":85,"role":66,"phone":86,"phoneExt":22,"email":87},"Jun Guo","13911233048","guoj307@126.com",{"type":89,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100498151",false,"NCT05766527","A Study of KM602 in Patients With Advanced Solid Tumors","A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically confirmed, disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments (predominantly melanoma and non-small cell lung cancer)\n2. All patients must have at least one measurable lesion at baseline according to RECIST v1.1\n3. ECOG performance status of 0 or 1\n4. Life expectancy of ≥ 12 weeks\n5. Adequate baseline hematologic, renal, and hepatic function\n\nExclusion Criteria:\n\n1. Patients with meningeal metastasis or symptomatic central nervous system metastasis\n2. Any second malignancy active within the previous 5 years\n3. Any active, known, or suspected autoimmune disease\n4. Active or prior pneumonitis or interstitial lung disease\n5. Prior organ allograft or allogeneic hematopoietic stem cell transplantation\n6. Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 4 weeks prior to the first dose of KM602\n7. Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab\n8. History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation\n9. Systemic treatment with corticosteroids (\\> 10 mg\u002Fday prednisone) or other immunosuppressive medication within 14 days prior to the first dose of KM602 or during the study\n10. Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C\n11. Known allergies, hypersensitivity, or intolerance to KM602 or excipients in the drug product formulation\n12. Active infection requiring therapy at the time of the first dose of KM602\n13. Pregnancy or breastfeeding\n14. Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.","ALL","18 Years","75 Years",{"count":100,"type":101},38,"ESTIMATED","INTERVENTIONAL",[104],"PHASE1","This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and activity of KM602 as monotherapy in patients with advanced solid tumors.",[107],"Advanced Solid Tumor","NOT_YET_RECRUITING","2023-03-09",{"date":111,"type":112},"2023-03-13","ACTUAL",{"date":114,"type":101},"2023-04",{"date":116,"type":101},"2026-12",{"name":5,"class":6},1]