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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 29, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07873450). This is a study registration, not published results. Lead sponsor: Full-Life Technologies UK Limited. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 208 participants (ESTIMATED). Conditions: Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer, Cholangiocarcinoma. Interventions: DRUG: [225Ac]Ac-FL-261; DRUG: [225Ac]Ac-FL-261; DRUG: [225Ac]Ac-FL-261. Primary outcome measures: Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs) , Until 28 days after the first injection of [225Ac]Ac-FL-261]; 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/SAEs. Thereafter, only AEs of special interest (AESIs) and related SAEs will be reported (up to 5 years); 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). Brief summary: This is a first-in-human, multicenter, open-label Phase 1/2 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.