Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
RAD-18-001 is a First-In-Man, Dose Escaltion 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. Acceptability of up to 7 MBq gives the opportunity to explore
the doses of the dose escalation split into two administrations, and given as two separate
injections 1 week apart. Split doses of 1, 2 and 3.5 MBq will be administered as two
injections. Each subject will be followed until disease progression (in the abdominal
cavity), or for 12 months after the administration of Radspherin® (whichever comes first).