# ALPHAMEDIX-02

Source: https://nuclide.cc/trials/alphamedix-02/  
Nuclide record `alphamedix-02` (Trial). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

An alpha-emitting radioligand met all its primary endpoints, with responses in more than half of patients new to radioligand therapy.

## Summary

ALPHAMEDIX-02, trial NCT05153772 sponsored by RadioMedix, Orano Med and Sanofi and reported in 2025, showed that the alpha-emitting radioligand 212Pb-DOTAMTATE met all its primary endpoints, with responses in more than half of patients with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumours who were new to radioligand therapy. In the single-arm phase 2 the objective response rate in PRRT-naive patients was 54.3 percent, most were still progression-free around three years, and the PRRT-exposed cohort was largely progression-free at eighteen months, as Sanofi reported in October 2025; the drug holds Breakthrough Therapy designation and the registrational path is being finalised. Nuclide links it to targeted alpha therapy, PRRT, 212Pb-DOTAMTATE and the pairing of beta then alpha PRRT. Whether a randomised trial confirms superiority over lutetium is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT05153772
- Phase: 2
- Setting: Unresectable or metastatic SSTR-positive GEP-NETs, PRRT-naive and PRRT-exposed cohorts: 212Pb-DOTAMTATE single arm
- Sponsor: RadioMedix / Orano Med / Sanofi
- Result: ORR 54.3% (PRRT-naive); all primary endpoints met.
- Outcomes: Objective response rate (PRRT-naive): 212Pb-DOTAMTATE 54.3%

## Sources

- ClinicalTrials.gov NCT05153772: https://clinicaltrials.gov/study/NCT05153772
- Sanofi press release: https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053

## Connected records

- isotopes: [Lead-212](https://nuclide.cc/isotopes/pb-212/)
- indications: [Neuroendocrine tumours](https://nuclide.cc/indications/neuroendocrine/)
- technologies: [Peptide receptor radionuclide therapy (PRRT)](https://nuclide.cc/technologies/prrt/), [Targeted alpha therapy](https://nuclide.cc/technologies/targeted-alpha-therapy/)
- drugs: [212Pb-DOTAMTATE](https://nuclide.cc/drugs/alphamedix/)
- pairings: [Beta PRRT → alpha PRRT](https://nuclide.cc/pairings/prrt-then-alpha-net/)
- roadmaps: [Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline](https://nuclide.cc/roadmaps/alpha-therapy-roadmap/), [SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha](https://nuclide.cc/roadmaps/sstr-theranostics-roadmap/)

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