{"entity":{"id":"alphamedix-02","kind":"trial","name":"ALPHAMEDIX-02","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05153772","url":"https://clinicaltrials.gov/study/NCT05153772"},{"label":"Sanofi press release","url":"https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053"}],"tags":[],"related":["pb-212"],"indications":["neuroendocrine"],"sections":[],"technologies":["targeted-alpha-therapy","prrt"],"targets":[],"drugs":["alphamedix"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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.","yearReported":2025,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (PRRT-naive)","primary":true,"unit":"%","arms":[{"name":"212Pb-DOTAMTATE","value":54.3}],"source":"https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053"}]},"route":"/trials/alphamedix-02/","neighbours":{"isotope":[{"id":"pb-212","kind":"isotope","name":"Lead-212","route":"/isotopes/pb-212/"}],"indication":[{"id":"neuroendocrine","kind":"indication","name":"Neuroendocrine tumours","route":"/indications/neuroendocrine/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"targeted-alpha-therapy","kind":"technology","name":"Targeted alpha therapy","route":"/technologies/targeted-alpha-therapy/"}],"drug":[{"id":"alphamedix","kind":"drug","name":"212Pb-DOTAMTATE","route":"/drugs/alphamedix/"}],"pairing":[{"id":"prrt-then-alpha-net","kind":"pairing","name":"Beta PRRT → alpha PRRT","route":"/pairings/prrt-then-alpha-net/"}],"roadmap":[{"id":"alpha-therapy-roadmap","kind":"roadmap","name":"Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline","route":"/roadmaps/alpha-therapy-roadmap/"},{"id":"sstr-theranostics-roadmap","kind":"roadmap","name":"SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha","route":"/roadmaps/sstr-theranostics-roadmap/"}]}}