drugset / Trial / NCT03466216

Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET

NCT03466216 ↗

Phase 1 Terminated 33 enrolled Orano Med LLC
NaSingle-groupOpen-labelTreatment

Summary

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications. This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.

Timeline

Start
2018-02-05
Primary completion
2023-04-06
Completion
2023-04-06

Outcome

Outcome not reported

Stopped: “Terminated for non-safety reasons.”

Drugs

EvaluationDrugModalityDoseRoute
Subject 212Pb-DOTAMTATE Other / unclassified — Intravenous