[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"grpr-positive-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:grpr-positive-solid-tumors":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641336","phase-1-a-study-of-177lulu-a9-0631-and-225acac-a9-0642-with-68gaga-a9-6217-or-177lulu-a9-0631-imaging-in-grpr-solid-tumors-100641336",false,"NCT07661641","A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors","A Phase 1-1b Study to Evaluate the Safety, Efficacy, and Dosimetry of [177Lu]Lu-A9-0631, [225Ac]Ac-A9-0642, and [68Ga]Ga-A9-6217 in Participants With GRPR+ Tumors","Inclusion Criteria:\n\n* Participant has provided written informed consent prior to any study-specific procedure.\n* Age ≥ 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have measurable target lesion per RECIST v1.1.\n* Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+\u002FHER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.\n* Have GRPR-expressing disease as confirmed by PET \u002F CT or SPECT imaging.\n* Adequate organ function within 14 days of first administration of investigational therapeutic product.\n* At least 4 weeks from prior major surgery.\n\nExclusion Criteria:\n\n* Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1\u002F2) whichever is shorter, to the administration of therapeutic investigational product.\n* History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.\n* Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.\n* Prior external beam radiation therapy to more than 25% of the bone marrow.\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Any active infection.","ALL","18 Years",{"count":19,"type":20},115,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of \\[177Lu\\]Lu-A9-0631 and \\[225Ac\\]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.",[26,27,28,29],"Breast Cancer","Prostate Cancer","Colorectal Cancer","GRPR-positive Solid Tumors",[31,32,33,34,35,36],"breast cancer","prostate cancer","colorectal cancer (CRC)","GRPR-positive solid tumors","radiopharmaceuticals","theranostics","RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-22","ACTUAL",{"date":43,"type":20},"2026-07-01",{"date":45,"type":20},"2029-12",{"name":47,"class":48},"Alpha-9 Oncology USA Inc.","INDUSTRY",2]