[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clasp Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641737","phase-1-a-study-of-clsp-5282-in-hla-a0301-positive-adult-patients-with-solid-tumors-sentinel-101-100641737",false,"NCT07650357","A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)","SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation","Inclusion Criteria:\n\n* Adults at least 18 years of age on the day of signing informed consent.\n* Willing and able to provide written informed consent for the study.\n* Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.\n* Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.\n* Patients must be HLA-A\\*03:01 positive by central assay.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Adequate hematological, renal and hepatic function.\n* Per Investigator judgement, patient is willing and able to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation.\n\nExclusion Criteria:\n\n* Patients who have received other KRas G12V directed cellular therapies or TCEs.\n* Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.\n* Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.\n* Patients who have not fully recovered from adverse events due to previous anticancer therapies\n* Patients with active infection requiring systemic antimicrobial therapy\n* Known primary malignant brain tumors, active central nervous system metastases and\u002For carcinomatous meningitis","ALL","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A\\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.",[26,27,28,29],"Advanced Solid Tumor","Non Small Cell Lung Cancer","Pancreatic Carcinoma","Colorectal Cancer",[31,32,33,34,35],"T-Cell Engager","TCE","Clasp-5282","KRas G12V mutation","HLA A*03:01","NOT_YET_RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":20},"2026-07",{"date":44,"type":20},"2029-07",{"name":46,"class":47},"Clasp Therapeutics, Inc.","INDUSTRY",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100575944","phase-1-a-study-of-clsp-1025-in-adult-patients-with-solid-tumors-that-harbor-the-p53-r175h-mutation-100575944","NCT06778863","A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation","GUARDIAN-101","Key Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Patients must be willing and able to provide written informed consent\n* Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists\n* Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test\n* Patients must be HLA-A\\*02:01 positive by central assay\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n* Adequate hematological, renal and hepatic function\n* Per Investigator judgement, patient is willing and able to complete study visits and\u002For procedures per the protocol and comply with study requirements for study participation\n\nKey Exclusion Criteria:\n\n* Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation\n* Patients who have received other p53 R175H-directed therapies\n* Patients who have not fully recovered from adverse events due to previous anticancer therapies\n* Patients with active infection requiring systemic antimicrobial therapy\n* Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.\n* Known active central nervous system metastases and\u002For carcinomatous meningitis",{"count":58,"type":20},90,[23],"Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.",[26,62,63,64,65,66,67,68,69,70,71],"Unresectable Solid Tumor","Metastatic Solid Tumor","Colorectal Adenocarcinoma","Pancreatic Adenocarcinoma","Lung Cancer","Ovarian Cancer","Breast Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Cancer","Bladder Cancer",[73,74,32,75],"CLSP-1025","T Cell Engager","TP53","RECRUITING","2026-02-12",{"date":79,"type":40},"2026-02-13",{"date":81,"type":40},"2025-02-28",{"date":83,"type":20},"2028-06",{"name":46,"class":47},21,""]