[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624970":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":73,"collaborators":54,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":54,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":54,"enrollmentInfo":84,"targetDuration":54,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":54,"overallStatus":61,"whyStopped":54,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 (Dosimetry)","EXPERIMENTAL","Participants will receive SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) administered intravenously (IV). During Cycle 1, following an initial dosing interval, participants will receive 203Pb-DOTAM for imaging-based dosimetry assessment, followed by administration of 212Pb-DOTAM.\n\nIn other cycles, participants will receive SPLIT Abs in combination with 212Pb-DOTAM only. Treatment will be administered every 4 weeks (Q4W) for up to 6 cycles. Each cycle is 28 days.",[13,14,15],"Drug: SPLIT Abs","Drug: 203Pb-DOTAM","Drug: 212Pb-DOTAM",{"label":17,"type":10,"description":18,"interventionNames":19},"Part 2 (212Pb-DOTAM Administered Activity Escalation)","Participants will receive SPLIT Abs at the dose and dosing interval selected in Part 1 in combination with 212Pb-DOTAM. The administered activity of 212Pb-DOTAM will be increased stepwise in each cohort to identify the maximum tolerated administered 212 activity (MTA) or a recommended Phase 2 administered activity (RP2A).",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Part 3 (Expansion)","Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2.",[13,15],[25,33,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","SPLIT Abs","Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.",[9,17,21],[31,32],"RO7782304","RO7782306",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"203Pb-DOTAM","Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.",[9,17],[38],"RO7205834-009",{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"212Pb-DOTAM","Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.",[9,17,21],[44],"RO7205834-010",[46],{"name":47,"affiliation":5,"role":48},"Clinical Trials","STUDY_DIRECTOR",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Reference Study ID Number: BP45930 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)",null,"global-roche-genentech-trials@gene.com",{"name":57,"role":52,"phone":54,"phoneExt":54,"email":54},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":54},"Nebraska Cancer Specialists","RECRUITING","Omaha","Nebraska","68130","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-95.94043,41.25626,{"lat":71,"lon":70},{"type":74,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100624970","phase-1-a-study-to-investigate-cea-prit-20-in-participants-with-metastatic-colorectal-cancer-mcrc-100624970",false,"NCT07416552","A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)","A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma originating from the colon or rectum\n* Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)\n* Confirmed MSS and\u002For proficient mismatch repair (MMR) status\n* Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease\n* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Life expectancy estimated by the Investigator to be \\>=12 weeks\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1\n* Adequate cardiovascular, hematological and renal function and laboratory parameters\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intending to become pregnant\n* Participants with active central nervous system (CNS) metastases\n* History of malignancy other than the one under investigation\n* Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure\n* Major surgery or significant traumatic injury \\\u003C4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Participants have a known confirmed positive test for HIV\n* Positive hepatitis B surface antigen (HBsAg) test, and\u002For positive total hepatitis B core Ab (HBcAb) test at screening.\n* Positive hepatitis C (HCV) Ab test result at screening\n* Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1\n* Prior treatment with a CEA-targeted agent or systemic radio therapy","ALL","18 Years",{"count":85,"type":86},180,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.",[92],"Metastatic Colorectal Cancer","2026-06-05",{"date":95,"type":96},"2026-06-09","ACTUAL",{"date":98,"type":86},"2026-06-16",{"date":100,"type":86},"2034-02-12",{"name":5,"class":6},1]