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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Able and willing to provide written informed consent and to comply with the clinical study protocol
✓. Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0.
✓. AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin®
✕. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes.
✕. Pregnant or lactating (nursing) women
✕. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever \>38.0 ⁰C associated with a clinical diagnosis of active infection
✕. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV
✕. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment
✕. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment