“These regulatory clearances represent an important milestone for FL-261 and our strategy to expand targeted alpha therapy into various solid tumors,” said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. “[225Ac]Ac-FL-261 is designed to selectively target c-MET-expressing tumors by delivering potent alpha radiation directly into the tumor sites. We look forward to advancing FL-261 into its Phase 1 trial and generating key clinical evidence that will help translate our preclinical findings and inform the continued development of this promising program.”
The planned first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of [225Ac]Ac-FL-261 in patients with nsNSCLC. Full-Life plans to conduct clinical development in the United States, Australia and other key