[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alpha-9 Oncology USA Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100598827","phase-1-a-phase-1-1b-study-to-evaluate-the-safety-efficacy-and-dosimetry-of-study-drug-a9-3408-in-subjects-with-metastatic-melanoma-100598827","NCT07076550","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n* Able to provide written informed consent\n* \\[68Ga\\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan\n* Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy\n* Adequate ECOG performance status\n* Adequate baseline organ function within 14 days of first dose of investigational product\n* Recovered from side effects of prior anticancer therapy\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of \\[225Ac\\]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of \\[225Ac\\]Ac-A9-3408\n\nExclusion Criteria:\n\n* Previous treatment with radioactive nuclides except radioactive imaging tracers\n* Treatment with another investigational product shortly prior to first dose of \\[225Ac\\]Ac-A9-3408 with exception of anti-PD-1\u002FPD-L1 agents.\n* Concurrent anticancer therapy\n* Major surgery within 4 weeks of first dose of investigational product\n* Second malignancy within 2 years\n* Active, clinically serious infection\n* Known infusion reactions to components of the investigational product\n* Other clinically serious health conditions including cardiovascular and or severe infectious diseases\n* Significant central nervous system metastatic disease\n* Pregnant, breastfeeding or unwilling to practice adequate birth control method(s)\n* Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent",{"count":57,"type":20},50,[23],"The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are:\n\n* What are the side effects of this investigational drug?\n* What is the highest dose of this investigational drug that can be given safely?\n\nParticipants will:\n\n* Take the investigational drug once every 6 weeks, for up to 6 times in total\n* Visit a doctor's office on a regular basis for checkups and tests",[61,62,63],"Melanoma Metastatic","Uveal Melanoma, Metastatic","Mucosal Melanoma",[65,66,67,68],"Metastatic Melanoma","Melanoma","Radiopharmaceuticals","Theranostic","2026-03-12",{"date":71,"type":41},"2026-03-16",{"date":73,"type":41},"2025-11-19",{"date":75,"type":20},"2028-01",{"name":47,"class":48},4,""]