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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |