[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660261":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":39,"armGroups":52,"interventions":61,"overallOfficials":39,"centralContacts":74,"locations":80,"responsibleParty":112,"collaborators":39,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":39,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":39,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":139,"overallStatus":151,"whyStopped":39,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Neowise Biotechnology","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":39},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors","Type, frequency, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormalities in vital signs, electrocardiograms (ECGs) and other laboratory results.","Through the study completion, an average of 2 years",{"measure":14,"description":15,"timeFrame":16},"Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D)","Number of participants with dose-limiting toxicities (DLTs) and their types.","28 days",{"measure":18,"description":19,"timeFrame":12},"Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D","Type, frequency, and severity of TEAEs, SAEs, and abnormalities in vital signs, ECGs and other laboratory results.",{"measure":21,"description":22,"timeFrame":23},"Phase 1b: Final RP2D of NW-301V","Determine the final RP2D of NW-301V","Up to 2 years",[25,28,30,32,34,37,40,42],{"measure":26,"description":27,"timeFrame":12},"Objective response rate (ORR)","Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)",{"measure":29,"description":27,"timeFrame":12},"Disease control rate (DCR)",{"measure":31,"description":27,"timeFrame":12},"Duration of response (DOR)",{"measure":33,"description":27,"timeFrame":12},"Progression-free survival (PFS)",{"measure":35,"description":36,"timeFrame":12},"Overall survival (OS)","(Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)",{"measure":38,"description":39,"timeFrame":12},"Maximum blood concentration (Cmax) of NW-301V",null,{"measure":41,"description":39,"timeFrame":12},"Time to maximum concentration (Tmax) of NW-301V",{"measure":43,"description":44,"timeFrame":12},"Persistence of NW-301V TCR-T cells in vivo","Determined by qPCR-measured gene copies",{"allocation":46,"interventionModel":47,"interventionModelDescription":39,"primaryPurpose":48,"observationalModel":39,"timePerspective":39,"maskingInfo":49},"NA","SEQUENTIAL","TREATMENT",{"masking":50,"maskingDescription":39,"whoMasked":39},"NONE","There are 2 parts in this study：\n\n* Phase 1a: Dose Escalation. A conventional 3+3 dose escalation design will be used to assess the safety\u002Ftolerability, pharmacokinetics (PK) and preliminary antitumor activity of NW-301V in participants with advanced or locally unresectable solid tumors who meet the enrollment criteria. A provisional Recommended Phase 2 Dose (RP2D) of NW-301V will be determined.\n* Phase 1b: Dose expansion. Participants with pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC) or lung adenocarcinoma (LUAD) who meet the eligibility criteria will be enrolled into three separate disease-specific cohorts. The final RP2D will be determined.\n\nParticipants who meet the protocol-defined eligibility criteria during screening will undergo leukapheresis for the manufacture of NW-301V. Prior to NW-301V infusion, participants will receive a lymphodepletion (LD) regimen consisting of fludarabine and cyclophosphamide. Participants will be closely monitored for safety, tolerability and treatment response throughout the study.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"NW-301V","EXPERIMENTAL","Participants receive lymphodepletion and a single infusion of NW-301V, an autologous TCR-T cell therapy targeting KRAS G12V. In Phase 1a (dose escalation), two dose levels at 4×10\\^9 (±30%) and 8×10\\^9 (±30%) TCR-T+ cells will be tested. In Phase 1b (dose expansion), NW-301V will be administered at provisional RP2D in 3 tumor-specific cohorts (Cohort A: pancreatic ductal adenocarcinoma; Cohort B: colorectal adenocarcinoma; Cohort C: lung adenocarcinoma), each containing around 20 participants.",[58,59,60],"Drug: Fludarabine","Drug: Cyclophosphamide","Biological: NW-301V",[62,67,70],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":39},"DRUG","Fludarabine","Used for lymphodepletion",[54],{"type":63,"name":68,"description":65,"armGroupLabels":69,"otherNames":39},"Cyclophosphamide",[54],{"type":71,"name":54,"description":72,"armGroupLabels":73,"otherNames":39},"BIOLOGICAL","NW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A\\*11:01, administered intravenously after lymphodepletion.",[54],[75],{"name":76,"role":77,"phone":78,"phoneExt":39,"email":79},"Rui Liu, Master Degree","CONTACT","+86-512-67991566","rui.liu@neowisebio.com",[81,98],{"facility":82,"status":39,"city":83,"state":84,"zip":39,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Beijing Cancer Hosptial","Beijing","Beijing Municipality","China","CN",{"type":88,"coordinates":89},"Point",[90,91],116.39723,39.9075,{"lat":91,"lon":90},[94],{"name":95,"role":77,"phone":96,"phoneExt":39,"email":97},"Lin Shen, MD","+86-10-88121122","doctorshenlin@sina.com",{"facility":99,"status":39,"city":100,"state":101,"zip":39,"country":85,"countryCode":86,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":88,"coordinates":103},[104,105],120.16142,30.29365,{"lat":105,"lon":104},[108],{"name":109,"role":77,"phone":110,"phoneExt":39,"email":111},"Tingbo Liang, MD, PhD","+86-571-87236114","liangtingbo@zju.edu.cn",{"type":113,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100660261","phase-1-phase-1-study-of-nw-301v-tcr-t-cells-in-advanced-solid-tumors-with-kras-g12v-mutation-100660261",false,"NCT07875920","Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation","A Single-Arm, Multicenter, Open-Label, Phase Ia\u002FIb Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations","Key Inclusion Criteria:\n\nApplicable to both Phase 1a and 1b:\n\n* Age between 18-75 years\n* HLA-A\\*11:01 positive\n* Tumor confirmed to have KRAS G12V mutation\n* At least one measurable lesion according to RECIST 1.1\n* ECOG 0-1\n* Life expectancy \\> 3 months before leukapheresis\n* Adequate organ functions prior to leukapheresis and lymphodepletion\n\nFor Phase 1a only:\n\n* Histologically or pathologically confirmed, advanced or unresectable solid tumors including, but not limited to, pancreatic ductal adenocarcinoma (PDAC), colorectal adenocarcinoma (CRC), and lung adenocarcinoma (LUAD)\n* Participants must have no standard treatment options available or are unable to tolerate currently available standard treatment\n\nFor Phase 1b only:\n\n* Cohort A: Histologically or pathologically confirmed advanced or locally advanced unresectable PDAC that had failed or progressed after at least 1 line of prior systemic therapy\n* Cohort B: Histologically or pathologically confirmed advanced CRC that had failed or progressed after at least 2 lines of prior systemic therapies\n* Cohort C: Histologically or pathologically confirmed advanced LUAD that had failed or progressed after at least 1 line of prior systemic therapy\n\n(Additional protocol-defined Inclusion criteria may apply)\n\nKey Exclusion Criteria:\n\nApplicable to both Phase 1a and 1b:\n\n* Received the following treatments: Cytotoxic chemotherapy or immunosuppressive agents within 2 weeks prior to leukapheresis, or within 1 week prior to lymphodepletion; Antibodies or other biologic therapy within 3 weeks prior to leukapheresis, or within 2 weeks prior to lymphodepletion;\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to leukapheresis or lymphodepletion\n* Have symptomatic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Inclusion criteria may apply)","ALL","18 Years","75 Years",{"count":125,"type":126},66,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This is a single-arm, multicenter, open-label, Phase 1a\u002F1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.",[132,133,134,135,136,137,138],"Advanced Solid Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Adenocarcinoma","Lung Adenocarcinoma","KRAS G12V","Pancreatic Cancer","Colorectal Cancer",[140,141,142,143,144,145,146,147,148,136,149,150],"TCR-T","TCR-T cell therapy","PDAC","CRC","LUAD","Pancreatic cancer","Colorectal cancer","NSCLC","KRAS","HLA-A*11:01","Solid tumors","NOT_YET_RECRUITING","2026-10-08",{"date":154,"type":155},"2026-10-15","ACTUAL",{"date":157,"type":126},"2026-10",{"date":159,"type":126},"2033-03",{"name":5,"class":6},2]