RadioMedix and Orano Med have dosed the last patient in the Phase II trial investigating the safety and effectiveness of targeted alpha-emitter AlphaMedix in neuroendocrine cancers. The completion of the patient enrolment was on schedule.
The Phase II trial (NCT05153772) is a multi-center, single arm, non-randomised, open-label basket trial involving 41 patients with somatostatin receptor-expressing neuroendocrine tumours (NET) who have not received peptide receptor radionuclide therapy (PRRT). Four cycles of AlphaMedix were administered at 8-week intervals. The primary endpoint of the trial is safety and effectiveness of AlphaMedix. Efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
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AlphaMedix is a radiolabeled somatostatin receptor (SSTR)-targeting therapeutic. Targeted Alpha Therapy (TAT) is based on the coupling of alpha particle emitting radioisotopes to tumour selective carrier molecules. The emission of alpha particles selectively destroys cancer cells.
Although data will be reported in 2024, the companies say that ORR has already been achieved at a level twice that of current standard of care.
“Previous studies have shown TAT with AlphaMedix is well-tolerated. The preliminary efficacy data seen to date are very promising, particularly achieving the planned ORR endpoint,” said Dr Ebrahim Delpassand, chairman and CEO of RadioMedix.
“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 FDA approved therapies for patients with metastatic or inoperable SSTR-expressing NETs.”
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