[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606072":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":11,"studyPopulation":11,"armGroups":57,"interventions":65,"overallOfficials":11,"centralContacts":75,"locations":81,"responsibleParty":96,"collaborators":11,"id":98,"slug":11,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":11,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":114,"conditions":115,"keywords":11,"overallStatus":117,"whyStopped":11,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"DLT\u002FMTD (Dose Escalation Phase)",null,"Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)",{"measure":14,"description":11,"timeFrame":15},"Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)","From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment",{"measure":17,"description":11,"timeFrame":18},"Objective Response Rate (ORR)","From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.",{"measure":20,"description":11,"timeFrame":21},"RP2D (Dose Extension Phase)","From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks",[23,25,27,29,31,35,38,41,44,47],{"measure":24,"description":11,"timeFrame":18},"Disease Control Rate(DCR)",{"measure":26,"description":11,"timeFrame":18},"Duration of Response (DOR)",{"measure":28,"description":11,"timeFrame":18},"progression- free survival(PFS)",{"measure":30,"description":11,"timeFrame":18},"overall survival（OS）",{"measure":32,"description":33,"timeFrame":34},"Cmax","Peak concentration (Cmax)","Up to approximately 1 year",{"measure":36,"description":37,"timeFrame":34},"Tmax","Peak time (Tmax)",{"measure":39,"description":40,"timeFrame":34},"AUC0-tlast","Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t)",{"measure":42,"description":43,"timeFrame":34},"AUC0-inf","Area under plasma concentration-time curve from 0 to infinite time",{"measure":45,"description":46,"timeFrame":34},"t1\u002F2","Elimination phase half-life (t1\u002F2), in single dose period.",{"measure":48,"description":49,"timeFrame":34},"CL","Clearance Rate",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":11,"timePerspective":11,"maskingInfo":55},"NA","SEQUENTIAL","Dose Escalation Phase:\n\nParticipants will receive IMM2510 10 mg\u002Fkg or 20mg\u002Fkg and combine with IMM01 1.0 mg\u002Fkg , 2.0 mg\u002Fkg or 3.0 mg\u002Fkg dose every 2 weeks (Q2W).\n\nDose Expansion Phase:\n\nThe dose of IMM2510 and IMM01 for the dose expansion phase is determined according to the dose escalation results.\n\nParticipants will receive IMM2510 and IMM01 every 2 weeks (Q2W).","TREATMENT",{"masking":56,"maskingDescription":11,"whoMasked":11},"NONE",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"Cohort 1","EXPERIMENTAL","Dose Escalation Phase:\n\nParticipants will receive IMM2510 10.0 mg\u002Fkg or 20.0 mg\u002Fkg dose every 2 weeks (Q2W), and will receive IMM01 1.0 mg\u002Fkg,2.0 mg\u002Fkg or 3.0 mg\u002Fkg dose every 2 weeks (Q2W).\n\nCohort Expansion Phase:\n\nThe dose of IMM2510 and IMM01 for the cohort expansion phase is determined according to the dose escalation results.\n\nParticipants will receive IMM2510 and IMM01 every 2 weeks (Q2W).",[63,64],"Biological: IMM2510","Biological: IMM01",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":11},"BIOLOGICAL","IMM2510","IMM2510 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM2510 (e.g., 10 mg\u002Fkg, 20 mg\u002Fkg, up to maximum tolerated dose or recommended phase 2 dose).",[59],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":11},"IMM01","IMM01 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM01 (e.g., 1 mg\u002Fkg, 2 mg\u002Fkg, 3mg\u002Fkg, up to maximum tolerated dose or recommended phase 2 dose).",[59],[76],{"name":77,"role":78,"phone":79,"phoneExt":11,"email":80},"Jin Li Chief Scientist","CONTACT","+86 13761222111","jin.li@gobroadhealthcare.com",[82],{"facility":83,"status":11,"city":84,"state":85,"zip":11,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Shanghai Gobroad Cancer Hospital China Pharmaceutical University","Shanghai","Shanghai Municipality","China","CN",{"type":89,"coordinates":90},"Point",[91,92],121.45806,31.22222,{"lat":92,"lon":91},[95],{"name":77,"role":78,"phone":79,"phoneExt":11,"email":80},{"type":97,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100606072",false,"NCT07170787","A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors","Phase Ib\u002FII Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors","Inclusion Criteria:\n\n* Participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n* Age greater than or equal to 18 years old at the same time of signing the informed consent.\n* Histologically or cytologically confirmed for Solid Tumor.\n* Eastern Cooperative Oncology Group (ECOG) 0 to 1.\n* Adequate organ function as defined in protocol.\n\nExclusion Criteria:\n\n* History of other malignancy within the past 5 years with exceptions.\n* Systemic chemotherapy was administered within 3 weeks prior to the first administration.\n* Activated symptomatic brain metastases and leptomeningeal disease.\n* History of inflammatory bowel disease.\n* Participants with symptoms and\u002For clinical signs and\u002For uncontrolled active systemic infection within 14 days prior to the first dose of study treatment.\n\nParticipant has known active infection requiring parenteral antibiotic treatment.","ALL","18 Years","75 Years",{"count":108,"type":109},104,"ESTIMATED","INTERVENTIONAL",[112,113],"PHASE1","PHASE2","This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.",[116],"Advanced Solid Tumors","NOT_YET_RECRUITING","2025-09-11",{"date":120,"type":121},"2025-09-12","ACTUAL",{"date":123,"type":109},"2025-10-15",{"date":125,"type":109},"2029-07",{"name":5,"class":6},1]