[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660169":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":11,"armGroups":50,"interventions":65,"overallOfficials":11,"centralContacts":77,"locations":83,"responsibleParty":100,"collaborators":11,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":11,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":11,"enrollmentInfo":111,"targetDuration":11,"studyType":114,"phases":115,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Full-Life Technologies UK Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs)",null,"Until 28 days after the first injection of [225Ac]Ac-FL-261]",{"measure":14,"description":11,"timeFrame":15},"2. Phase 1 Dose Escalation and Phase 1 Dose Optimization: Type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0","From ICF signature and up to 35 days after the last dose of study treatment for all AEs\u002FSAEs. Thereafter, only AEs of special interest (AESIs) and related SAEs will be reported (up to 5 years)",{"measure":17,"description":11,"timeFrame":18},"Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.","Every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 5 years)",[20,23,26,28,30,32,35,38,40],{"measure":21,"description":11,"timeFrame":22},"Phase 1 and Phase 2: Duration of response (DoR)","Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)",{"measure":24,"description":11,"timeFrame":25},"Phase 1 and Phase 2: Disease control rate (DCR)","Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)]",{"measure":27,"description":11,"timeFrame":22},"Phase 1 and Phase 2: Progression-free survival (PFS) by RECIST v1.1",{"measure":29,"description":11,"timeFrame":22},"Phase 1 and Phase 2: Overall survival (OS)",{"measure":31,"description":11,"timeFrame":22},"Phase 1: ORR by RECIST v1.1",{"measure":33,"description":11,"timeFrame":34},"Phase 1 and Phase 2: Peak plasma concentration (Cmax) of [225Ac]Ac-FL-261","Phase 1: Up to Day 15 of Cycle 1 and Cycle 2 (each cycle is 28 days); and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1",{"measure":36,"description":11,"timeFrame":37},"Phase 1 and Phase 2: Time to achieve Cmax (tmax)","Phase 1: Up to Day 15 of Cycle 1 and Cycle 2; and on the first day of Cycle 3 and Cycle 4. Phase 2: Up to Day 15 of Cycle 1",{"measure":39,"description":11,"timeFrame":37},"Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC)",{"measure":41,"description":11,"timeFrame":42},"Phase 2: Type, frequency, and severity of AEs and SAEs using NCI CTCAE v6.0.","From ICF signature and up to 35 days after the last dose of study treatment for all AEs\u002FSAEs. Thereafter, only AESIs and related SAEs will be reported (up to 5 years)",{"allocation":44,"interventionModel":45,"interventionModelDescription":11,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":48,"maskingDescription":11,"whoMasked":11},"NONE","Phase 1: Dose Escalation\n\n\\[225Ac\\]Ac-FL-261 will be administered at increasing doses in participants with non-squamous non-small cell lung cancer (ns-NSCLC) to identify the maximum tolerated dose (MTD) based on a BOIN design.\n\nPhase 1 - Dose Optimization\n\nAfter Dose Escalation is complete, 2 treatment regimens will be compared to select the optimal treatment regimen (OTR) between them.\n\nPhase2\n\nParticipants with ns-NSCLC, colorectal cancer, head and neck cancer and cholangiocarcinoma will be enrolled into separate cohorts to estimate the efficacy of \\[225Ac\\]Ac-FL-261 at the OTR in each indication.",[51,57,61],{"label":52,"type":53,"description":54,"interventionNames":55},"Phase 1 - Dose Escalation","EXPERIMENTAL","Dose escalation will use the Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD).",[56],"Drug: [225Ac]Ac-FL-261",{"label":58,"type":53,"description":59,"interventionNames":60},"Phase 1 - Dose Optimization","Randomized comparison of two candidate dosing regimens to select the optimal treatment regimen (OTR) for Phase 2.",[56],{"label":62,"type":53,"description":63,"interventionNames":64},"Phase 2","The optimal dose and regimen is tested in separate cohorts by tumor type, using a two-stage design.",[56],[66,71,74],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":11},"DRUG","[225Ac]Ac-FL-261","Dose escalation per BOIN design to determine MTD.",[52],{"type":67,"name":68,"description":72,"armGroupLabels":73,"otherNames":11},"Two candidate dosing regimens, randomized 1:1 (30 participants per arm)",[58],{"type":67,"name":68,"description":75,"armGroupLabels":76,"otherNames":11},"* Non-squamous non-small cell lung cancer (NSCLC)\n* Colorectal cancer (CRC)\n* Head and neck squamous cell carcinoma (HNSCC)\n* Cholangiocarcinoma",[62],[78],{"name":79,"role":80,"phone":81,"phoneExt":11,"email":82},"Full-Life Technologies","CONTACT","617-939-7858","clinicaltrials@t-full.com",[84],{"facility":85,"status":86,"city":87,"state":11,"zip":11,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Full-Life Technologies Investigational Site","RECRUITING","Nedlands","Australia","AU",{"type":91,"coordinates":92},"Point",[93,94],115.8073,-31.98184,{"lat":94,"lon":93},[97],{"name":98,"role":80,"phone":99,"phoneExt":11,"email":82},"Global Study Lead","6179397858",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":112,"type":113},208,"ESTIMATED","INTERVENTIONAL",[116,117],"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.",[120,121,122,123,124],"Solid Tumor","NSCLC","Colorectal Cancer","Head and Neck Cancer","Cholangiocarcinoma",[126,127,128,129,130,131,132,133,134,135],"Non small cell lung cancer","metastatic NSCLC","advanced NSCLC","H&N cancer","bile duct cancers","CRC","Phase 1","dose escalation","dose optimization","phase 2","2026-10-15",{"date":138,"type":139},"2026-10-16","ACTUAL",{"date":141,"type":113},"2026-10-01",{"date":143,"type":113},"2030-06-30",{"name":5,"class":6},1]