Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis

Summary

RAD-18-001 is a First-In-Man, Dose Escalation study conducted at 2 sites. The dose escalation will be performed based on a 3 + 3 design. Increasing dose levels starting at 1 MBq will be followed by 2, 4 and 7 MBq. If the highest dose level of 7 MBq is reached without Dose Limiting Toxicicities (which will stop the dose escalation), this will be the recommended dose for further exploration. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first). In the expansion cohort the subject will receive the recommended dose. The expansion cohort will be conducted at 4 sites. Each subject will be followed until disease progression (in the abdominal cavity), or for 24 months after the administration of Radspherin® (whichever comes first).

Timeline

Start

2020-06-08

Primary completion

2025-09-30

Completion

2025-09-30

Publications

• Wang Y, Van Nieuwenhuysen E, Revheim ME, Deroose CM, Eriksson AGZ, Eyjolfsdottir B, Van Gorp T, Baert T, Aksnes AK, Myren K, Vergote I, Bruland OS. First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. Gynecol Oncol. 2026 Jan;204:158-164. doi: 10.1016/j.ygyno.2025.11.018. Epub 2025 Dec 4.

Drugs

Indications