NCT03732768

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

A Phase 1 Study to Evaluate the Dose, Safety and Tolerability of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Platinum Sensitive Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis Following CRS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Oncoinvent Solutions AS · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The maximum number of subjects enrolled in this study is 49. The following number of subjects will be recruited in the different cohorts: * Dose escalation cohorts: 3 - 24 Subjects * Expansion cohort: Up to 25 Subjects

Conditions

• Peritoneal Carcinomatosis
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Radspherin	Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site.

Timeline

• Start date: 2020-06-08
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2018-11-07
• Last updated: 2026-04-17

Locations

4 sites across 3 countries: Belgium, Norway, Spain