[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Full-Life Technologies UK Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":55},{"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":25,"conditions":26,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100660169","phase-1-summet-study-of-225acac-fl-261-in-participants-with-solid-tumors-overexpressing-c-met-100660169",false,"NCT07873450","SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET","A First-in-Human Phase 1\u002F2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET","Inclusion Criteria:\n\n* They have signed the consent form before any study-related tests or procedures are done and are willing to follow all study requirements.\n* They are 18 years of age or older.\n* They have a confirmed diagnosis of an advanced or metastatic cancer that cannot be cured with surgery, radiation, or other treatments.\n* Phase 1: Non-squamous non-small cell lung cancer (ns-NSCLC).\n* Phase 2: Non-squamous non-small cell lung cancer (ns-NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), or cholangiocarcinoma (bile duct cancer).\n* Their cancer has worsened after previous treatments, or they cannot receive further standard treatments because of reasons such as side effects or medical conditions.\n* For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.\n* For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.\n* For head and neck cancer (HNSCC): Previously treated with platinum-based chemotherapy and immunotherapy.\n* For cholangiocarcinoma: Previously treated with at least one chemotherapy regimen.\n* The cancer must be c-MET positive, meaning laboratory testing of the tumor shows a moderate to high level of c-MET protein in at least half of the cancer cells.\n* At least one tumor can be measured on scans according to standard cancer assessment criteria.\n* The participant is generally well enough for daily activities, with an ECOG Performance Status of 0 or 1 (fully active or only restricted in strenuous activities).\n* Important organs are functioning adequately, based on blood and laboratory test results, including:\n* Normal heart rhythm measurement (QTc interval).\n* Women who can become pregnant must have a negative pregnancy test during screening and again shortly before starting study treatment.\n* Women who can become pregnant must use an effective birth control method from the first dose of study treatment until 6 months after the last dose.\n* Sexually active men must use a barrier method of contraception (such as condoms) during the study and for about 3 months after the last dose. They must also not donate sperm during this period.\n\nExclusion Criteria:\n\n* Cancer has spread to the brain or spinal cord and has not been treated.\n* People with previously treated brain metastases may still be eligible if they are stable, have no symptoms, and are not taking steroids for neurological problems.\n* They have a serious medical or mental health condition that could make participation unsafe or affect the study results.\n* They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment).\n* They received anti-cancer treatment within the last 4 weeks before starting the study drug.\n\nThey received an experimental (investigational) anti-cancer treatment within the last 4 weeks or within 5 half-lives of that treatment (whichever period is longer).\n\n* They received radiation therapy too recently, including:\n\n  * Radiation to a large area of bone marrow within 6 weeks before study treatment, or\n  * Radiation to a specific area within 2 weeks before study treatment.\n* They had major surgery within the last 6 weeks or have not completely recovered from the surgery and its side effects.\n* They are allergic to the study drug or any of its ingredients.\n* They are currently participating in another clinical trial that involves treatment or intervention.\n* They still have significant side effects from previous cancer treatments.\n\n  * People may still be eligible if they have:\n  * Hair loss of any severity,\n  * Mild to moderate nerve damage (Grade 2),\n  * Moderate fatigue (Grade 2),\n  * Stable diabetes,\n  * Well-controlled underactive or overactive thyroid disease.\n* They have a history of interstitial lung disease (a serious lung condition that causes scarring and inflammation of the lungs).\n* They have serious heart disease, including:\n\n  * Heart attack within the last 6 months,\n  * Unstable chest pain (angina),\n  * Moderate to severe heart failure,\n  * Uncontrolled high blood pressure,\n  * Uncontrolled abnormal heart rhythms,\n  * Severe narrowing of the aortic heart valve.\n* They have an active infection that requires treatment, including:\n\n  * HIV,\n  * Hepatitis B,\n  * Hepatitis C,\n  * COVID-19 (SARS-CoV-2).\n\nHowever, some people with chronic HIV, hepatitis B, or hepatitis C may be allowed to participate if their infection is well controlled and approved by the study doctor.\n\n* They have had another type of active cancer within the last 3 years, apart from the cancer being studied.\n\n  * Some exceptions may be allowed if the other cancer is well controlled and does not require treatment during the study.\n* They are pregnant or breastfeeding, or plan to become pregnant or donate eggs during the study or within 6 months after the last dose of the study drug.","ALL","18 Years",{"count":19,"type":20},208,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human, multicenter, open-label Phase 1\u002F2 study designed to evaluate the safety, efficacy, and tolerability of \\[225Ac\\]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Phase 1 will identify the recommended dose through dose escalation, followed by a randomized comparison of two candidate dosing regimens (dose optimization). In Phase 2, the selected dose will be tested in independent cohorts by tumor type.",[27,28,29,30,31],"Solid Tumor","NSCLC","Colorectal Cancer","Head and Neck Cancer","Cholangiocarcinoma",[33,34,35,36,37,38,39,40,41,42],"Non small cell lung cancer","metastatic NSCLC","advanced NSCLC","H&N cancer","bile duct cancers","CRC","Phase 1","dose escalation","dose optimization","phase 2","RECRUITING","2026-10-15",{"date":46,"type":47},"2026-10-16","ACTUAL",{"date":49,"type":20},"2026-10-01",{"date":51,"type":20},"2030-06-30",{"name":53,"class":54},"Full-Life Technologies UK Limited","INDUSTRY",""]