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RECRUITING
NCT07873450
PHASE1/PHASE2

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

Sponsor: Full-Life Technologies UK Limited

View on ClinicalTrials.gov

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.

Official title: A First-in-Human Phase 1/2 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2026-10-01

Completion Date

2030-06-30

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DRUG

[225Ac]Ac-FL-261

Dose escalation per BOIN design to determine MTD.

DRUG

[225Ac]Ac-FL-261

Two candidate dosing regimens, randomized 1:1 (30 participants per arm)

DRUG

[225Ac]Ac-FL-261

* Non-squamous non-small cell lung cancer (NSCLC) * Colorectal cancer (CRC) * Head and neck squamous cell carcinoma (HNSCC) * Cholangiocarcinoma

Locations (1)

Full-Life Technologies Investigational Site

Nedlands, Australia