drugset / Trial / NCT06411301

A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients With Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors

NCT06411301

NaSingle-groupOpen-labelTreatment

Summary

This study aims to determine the safety and the recommended phase II dose of RYZ101 (actinium-225 labelled DOTA-octreotate (225Ac-DOTATATE)) in participants with refractory and relapsing multiple myeloma (MM) that have received at least 3 prior lines of myeloma therapy. Participants will be selected based on somatostatin receptor (SSTR) positivity assessed by gallium-68 labelled DOTA-octreotate (68Ga-DOTATATE) PET/CT. The response to 225Ac-DOTATATE therapy will also be assessed in the target study population.

Timeline

Start
2024-10
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ACTINIUM DOTATATE Other / unclassified 5 mbq Intravenous
Subject ACTINIUM DOTATATE Other / unclassified 7.5 mbq Intravenous
Subject ACTINIUM DOTATATE Other / unclassified 10 mbq Intravenous

Indications