SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET

StatusRecruiting
PhasePhase 1/2
Started

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Record History

  1. Recruitment opened
    • Study sites: 0 to 1
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07873450
Lead Sponsor Full-Life Technologies UK Limited
Conditions
(from sponsor)		 Solid Tumor, NSCLC, Colorectal Cancer, Head and Neck Cancer, Cholangiocarcinoma
Related terms Bile Duct Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Colorectal Neoplasms, Head and Neck Neoplasms
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov