[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635743":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":60,"studyPopulation":57,"armGroups":61,"interventions":68,"overallOfficials":57,"centralContacts":74,"locations":57,"responsibleParty":80,"collaborators":84,"id":90,"slug":57,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":57,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":116,"whyStopped":57,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":57},{"fullName":5,"class":6},"Zhejiang Provincial People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":45},[9,12],{"measure":10,"description":10,"timeFrame":11},"Incidence of Dose-Limiting Toxicities (DLTs)","Within 21 days after the first dose",{"measure":13,"description":10,"timeFrame":14},"Incidence and Severity of Treatment-Related Adverse Events (TRAEs)","Up to 12 months",[16,19,23,26,29,32,36,39,42],{"measure":17,"description":18,"timeFrame":11},"Maximum Tolerated Dose (MTD)","MTD is defined as the highest dose level at which no more than 1 out of 6 participants experiences a dose-limiting toxicity (DLT) during the first treatment cycle, based on a standard 3+3 dose-escalation design.",{"measure":20,"description":21,"timeFrame":22},"Pharmacokinetic Parameters (Cmax)","Plasma pharmacokinetic parameters of allogeneic WTX-212C, including maximum observed concentration (Cmax）will be estimated using non-compartmental analysis methods.","From first dose up to 12 months",{"measure":24,"description":25,"timeFrame":14},"Objective Response Rate (ORR)","ORR is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria, based on investigator assessment.",{"measure":27,"description":28,"timeFrame":14},"Disease Control Rate (DCR)","DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1 criteria.",{"measure":30,"description":31,"timeFrame":14},"Progression-Free Survival (PFS)","PFS is defined as the time from the first dose of allogeneic WTX-212C to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.",{"measure":33,"description":34,"timeFrame":35},"Incidence of Anti-Drug Antibodies (ADA)","The incidence of anti-drug antibodies (ADA) against allogeneic WTX-212C will be assessed using validated immunoassays.","From baseline up to 12 months",{"measure":37,"description":38,"timeFrame":22},"Pharmacokinetic Parameters (AUC)","Plasma pharmacokinetic parameters of allogeneic WTX-212C，area under the concentration-time curve (AUC), will be estimated using non-compartmental analysis methods.",{"measure":40,"description":41,"timeFrame":22},"Pharmacokinetic Parameters (Tmax)","Plasma pharmacokinetic parameters of allogeneic WTX-212C, time to maximum concentration (Tmax) will be estimated using non-compartmental analysis methods.",{"measure":43,"description":44,"timeFrame":22},"Pharmacokinetic Parameters (T1\u002F2)","Plasma pharmacokinetic parameters of allogeneic WTX-212C, and terminal elimination half-life (t1\u002F2) will be estimated using non-compartmental analysis methods.",[46,49],{"measure":47,"description":48,"timeFrame":35},"Changes in Immune Cell Subsets in Peripheral Blood","Quantitative and phenotypic analysis of peripheral blood immune cell subsets (e.g., T cells, B cells, NK cells) will be performed using flow cytometry to assess immunological changes following treatment.",{"measure":50,"description":51,"timeFrame":14},"Exposure-Response Relationship","The relationship between pharmacokinetic exposure parameters (e.g., Cmax, AUC) and clinical outcomes (safety and efficacy endpoints) will be explored using descriptive and model-based analyses.",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":57,"timePerspective":57,"maskingInfo":58},"NA","SEQUENTIAL","This is a sequential assignment study consisting of a dose-escalation phase followed by a dose-expansion phase.\n\nThe dose-escalation phase will follow a standard 3+3 design with predefined dose levels. Dose escalation decisions will be based on the occurrence of dose-limiting toxicities (DLTs) observed during the first treatment cycle.\n\nUpon identification of a tolerable dose level, one or more dose-expansion cohorts may be opened to further characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of allogeneic WTX-212C.","TREATMENT",null,{"masking":59,"maskingDescription":57,"whoMasked":57},"NONE","This Phase I study aims to characterize the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), pharmacokinetics, immunogenicity, and preliminary efficacy of allogeneic WTX-212C in patients with advanced solid tumors.\n\nThe dose-escalation phase will follow a traditional 3+3 design with predefined dose levels. The dose-expansion phase will further evaluate safety, PK, and antitumor activity at selected dose levels.\n\nExploratory analyses will include immune profiling, tumor microenvironment assessment, and evaluation of biomarkers such as PD-1\u002FPD-L1 expression, tumor mutational burden (TMB), and microsatellite instability (MSI) status.",[62],{"label":63,"type":64,"description":65,"interventionNames":66},"Experimental: Allogeneic WTX-212C","EXPERIMENTAL","Participants will receive allogeneic WTX-212C via intravenous infusion in dose-escalation and dose-expansion cohorts.",[67],"Drug: allogeneic WTX-212C",[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":57},"DRUG","allogeneic WTX-212C","allogeneic WTX-212C is an investigational allogeneic engineered red blood cell-based injectable product administered intravenously.",[63],[75],{"name":76,"role":77,"phone":78,"phoneExt":57,"email":79},"Yang Liu, PhD","CONTACT","8613666601475","Yangliuqq2003@163.com",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Liu Yang","Principal Investigator",[85,88],{"name":86,"class":87},"Westlake Therapeutics","INDUSTRY",{"name":89,"class":6},"First People's Hospital of Hangzhou","100635743",false,"NCT07556653","Allogeneic WTX-212C in Advanced Solid Tumors","A Multicenter, Open-label, Single-arm Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Allogeneic WTX-212C Engineered Red Blood Cell Injection in Patients With Advanced Solid Tumors","WTX-212C-IIT","Inclusion Criteria:\n\n* Age 18-75 years\n* Histologically or cytologically confirmed advanced solid tumors\n* At least one measurable lesion per RECIST 1.1\n* ECOG performance status ≤1\n* Adequate organ function\n* Life expectancy ≥12 weeks\n\nExclusion Criteria:\n\n* Uncontrolled serious medical conditions\n* Active or uncontrolled infections\n* Symptomatic or unstable CNS metastases\n* History of severe hypersensitivity to biologic agents\n* Autoimmune diseases requiring systemic treatment\n* Prior severe immune-related adverse events\n* Conditions affecting red blood cell integrity","ALL","18 Years","75 Years",{"count":101,"type":102},24,"ESTIMATED","INTERVENTIONAL",[105],"EARLY_PHASE1","This is a multicenter, open-label, single-arm Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of allogeneic WTX-212C, an investigational allogeneic engineered red blood cell (RBC)-based product, in patients with advanced solid tumors who have failed standard therapies or have no available standard treatment options.\n\nThe study consists of a dose-escalation phase using a 3+3 design followed by a dose-expansion phase. Participants will receive allogeneic WTX-212C via intravenous infusion. Tumor assessments will be performed every 6 weeks according to RECIST 1.1.",[108],"Advanced Solid Tumors",[110,111,112,113,114,115],"Engineered Red Blood Cells","Immunotherapy","Phase I","Solid Tumor","Allogeneic Engineered Red Blood Cell","uRBC","NOT_YET_RECRUITING","2026-04-21",{"date":119,"type":120},"2026-04-29","ACTUAL",{"date":122,"type":102},"2026-04-10",{"date":124,"type":102},"2028-04-09",{"name":5,"class":6}]