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).
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
49
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.
UZ Leuven
Leuven, Belgium
The Norwegian Radiumhospital
Oslo, Norway
Clínica Universidad de Navarra
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Number of participants with Dose Limiting Toxicities as assessed by CTCAE v5.0.
To investigate safety and toxicity of Radspherin®
Time frame: 24 months
Maximum Tolerated Dose (MTD)
To determine the MTD of Radspherin®, among the four suggested doses 1, 2, 4 and 7 MBq, as a single intraperitoneal (IP) injection and two repeated IP injections following cytoreductive surgery (CRS)
Time frame: 21 days
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