Full-Life Technologies Reports First-in-Human Imaging Data for c-MET-Targeting Theranostic Ligand FL-261 Showing Robust Tumor Uptake, High Lesion Contrast and No Tracer-Related Serious Adverse Events in Patients with NSCLC

On October 19, 2026 Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage global radiopharmaceutical company, reported first-in-human imaging data for [111In]In-FL-261, its c-MET-targeted theranostic radionuclide drug conjugate ("RDC") program, in a Top Rated Oral Presentation at the 39th Annual Congress of the European Association of Nuclear Medicine ("EANM"), which is being held October 17 to 21, 2026, in Vienna, Austria.

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The presented data from patients with non-small cell lung cancer ("NSCLC") demonstrated high lesion contrast, no tracer-related serious adverse events and support the continued evaluation of [225Ac]Ac-FL-261 in clinical trials. Full-Life is also presenting an E-Poster, highlighting preclinical data in which [225Ac]Ac-FL-261 produced marked tumor regression in tumor cell-derived and patient-derived xenograft models with varying levels of c-MET expression.

"We are excited to share, for the first time, clinical imaging data showing FL-261’s potential for patients with c-MET-expressing NSCLC," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "These data demonstrate compelling FL-261 uptake in lesions with high contrast, no tracer-related serious adverse events and uptake that rose with c-MET expression in the patients studied, with favorable tumor to normal tissue ratios. Together with the recent regulatory clearances, the data provide strong support to advance [225Ac]Ac-FL-261 into the SumMET Phase 1 trial."

"c-MET is an oncogenic driver and a mediator of resistance to treatment in lung cancer, which makes it a meaningful target for precision therapy," said Prof. Xiaoli Lan, Department of Nuclear Medicine, Union Hospital, Tongji Medical College. "Being able to see c-MET expression across the whole body, noninvasively in this first cohort, is an encouraging step toward matching radioligand therapy to the patients who can benefit."

In September 2026, Full-Life announced that the U.S. Food and Drug Administration had cleared the Investigational New Drug application for [225Ac]Ac-FL-261 and that the program had also received regulatory clearances in Australia and China. Together, the clearances allow the Phase 1 SumMET trial (NCT07873450) of [²²⁵Ac]Ac-FL-261 to proceed at sites in these countries for patients with non-squamous NSCLC that expresses c-MET.

First-in-human imaging data (Top Rated Oral Presentation, OP-442)

The Top Rated Oral Presentation reports results from a prospective clinical trial of [111In]In-FL-261 in 10 patients with histologically confirmed NSCLC, designed to evaluate safety, biodistribution and diagnostic performance. Patients underwent SPECT/CT imaging 4, 24 and 72 hours after injection, and had a baseline [18F]FDG PET/CT for comparison.

Mean patient age was 65.3 years (range 59 to 71), and nine of 10 patients were male. Histology was adenocarcinoma in five patients, squamous cell carcinoma in four and NSCLC not otherwise specified in one. One patient had MET exon 14 skipping and two had no MET alteration detected, and seven were not tested.

Key findings

c-MET-specific lesion uptake: Tumor SUVmax at 4, 24, and 72 hours was 13.8, 25.7 and 43.2 respectively for a patient with high c-MET immunohistochemistry (IHC) score and 12.7, 22.9 and 20.7 respectively for a patient with moderate IHC score. The ratio of tumor SUVmax versus kidney and bone marrow SUVmean was in the range of 2.8-20.3 and 17.4-72.4 respectively for these two patients at all acquired time points.
Potential of c-MET diagnostic: Across six patients with available c-MET IHC scores, [111In]In-FL-261 uptake in the lesions showed a positive trend with c-MET expression (Spearman rho 0.82, P = 0.034), whereas [18F]FDG uptake did not (rho -0.13, P = 0.80).
Normal organ biodistribution: The uptake of the tracer in normal organs was generally low and all with rapid washout. The organs with highest uptake were liver, spleen and kidneys.
Safety: [111In]In-FL-261 was well tolerated in all patients, with no tracer-related serious adverse events.
Preclinical data (E-Poster #0035)

Full-Life is also presenting E-Poster #0035 "Development of FL-261 as a theranostic RDC vector for the diagnosis and treatment of c-MET positive cancers" at EANM.

The E-Poster describes the discovery and preclinical characterization of FL-261. [111In]In-FL-261 showed potent, c-MET-specific binding and rapid internalization in c-MET-overexpressing cells and in tumor-bearing mice. Tumor uptake exceeded that of normal organs and was nearly completely blocked by unlabeled FL-261. [225Ac]Ac-FL-261 produced marked tumor regression in xenograft models with varying levels of c-MET expression, including a model derived from a patient previously treated with a c-MET-targeted antibody-drug conjugate, with no notable changes in body weight.

Presentation details

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