Clinical Trials

US-based RadioMedix and French Orano Med, two clinical stage radiopharmaceutical companies, have announced that the last patient has been enrolled in the phase 2 trial of their targeted alpha emitter therapy.

The therapy, AlphaMedix (212Pb-DOTAMTATE), is indicated for use in peptide receptor radionuclide therapy (PRRT) of naïve patients with somatostatin receptor-expressing neuroendocrine tumours (NET), regardless of the location of the tumour.

Forty-one patients with histologically confirmed NETs and positive somastostatin analogue imaging who had not received prior PRRT are enrolled in the phase 2, multicentre, single-arm, non-randomised, open-label basket trial. The treatment consists of four cycles of AlphaMedix at eight-week intervals.

The primary endpoint of the trial is the safety and effectiveness of AlphaMedix, with efficacy endpoints consisting of objective response rate (ORR)usingRECISTv1.1criteria,progression-free survival (PFS) and overall survival (OS).

Ebrahim Delpassand MD, chairman and CEO of RadioMedix stated: “The completion of the phase 2 trial enrolment is a significant milestone in the clinical development of our innovative targeted alpha-emitter radiotherapy,

AlphaMedix, and brings us one step closer to having this drug available to patients. Previous studies have shown targeted alpha therapy (TAT) with AlphaMedix is well tolerated. The preliminary efficacy data seen to date are very promising, particularly achieving the planned ORR endpoint. As the trial progresses, we believe the ORR could improve further. We look forward to reporting data on the study in 2024, which we believe will show that AlphaMedix will provide substantial benefit over currently US Food and Drug Administration (FDA) approved therapies for patients with metastatic or inoperable SSTR-expressing NETs.”