[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641737":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":91,"collaborators":24,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":24,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":24,"enrollmentInfo":102,"targetDuration":24,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":120,"whyStopped":24,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Clasp Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A Monotherapy Dose Escalation","EXPERIMENTAL","Dose Escalation of CLSP-5282 in HLA A\\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.",[13],"Drug: CLSP-5282",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B Monotherapy Expansion","Dose expansion of CLSP-5282 in indication-specific cohorts in pancreatic adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung carcinoma (NSCLC) as well as an all-other solid tumor cohort conducted at the RDE.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","CLSP-5282","CLSP-5282 to be administered by IV infusion",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Lauren Harshman, MD","Clasp Therapeutics","STUDY_DIRECTOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+1-617-812-1431","LHarshman@clasptx.com",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":24},"Lauren Harshman",[38,51,65,78],{"facility":39,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Duke Cancer Institute","Durham","North Carolina","27701","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-78.89862,35.99403,{"lat":49,"lon":48},{"facility":52,"status":24,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Thomas Jefferson University, Sidney Kimmel Cancer Center","Philadelphia","Pennsylvania","19107",{"type":46,"coordinates":57},[58,59],-75.16362,39.95238,{"lat":59,"lon":58},[62],{"name":63,"role":32,"phone":24,"phoneExt":24,"email":64},"Aliya Rogers","axr028@jefferson.edu",{"facility":66,"status":24,"city":67,"state":68,"zip":69,"country":43,"countryCode":44,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Sarah Cannon Research Institute (SCRI) Oncology Partners","Nashville","Tennessee","37203",{"type":46,"coordinates":71},[72,73],-86.78444,36.16589,{"lat":73,"lon":72},[76],{"name":24,"role":32,"phone":77,"phoneExt":24,"email":24},"615-329-7640",{"facility":79,"status":24,"city":80,"state":81,"zip":82,"country":43,"countryCode":44,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Mary Crowley Cancer Research","Dallas","Texas","75230",{"type":46,"coordinates":84},[85,86],-96.80667,32.78306,{"lat":86,"lon":85},[89],{"name":24,"role":32,"phone":90,"phoneExt":24,"email":24},"972-566-3000",{"type":92,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":103,"type":104},140,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110,111,112,113],"Advanced Solid Tumor","Non Small Cell Lung Cancer","Pancreatic Carcinoma","Colorectal Cancer",[115,116,117,118,119],"T-Cell Engager","TCE","Clasp-5282","KRas G12V mutation","HLA A*03:01","NOT_YET_RECRUITING","2026-06-10",{"date":123,"type":124},"2026-06-16","ACTUAL",{"date":126,"type":104},"2026-07",{"date":128,"type":104},"2029-07",{"name":5,"class":6},4]