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Phase 2 Study of Radspherin® for Advanced Ovarian Cancer with Peritoneal Metastasis

This study is testing Radspherin®, a treatment that uses tiny particles with a radioactive substance (224Ra) to target cancer cells. It's for women aged 18 or older with advanced ovarian, fallopian tube, or primary peritoneal cancer that has spread to the lining of the abdomen (peritoneal metastasis). You would be scheduled to receive chemotherapy before surgery (neoadjuvant chemotherapy) and then have surgery to remove tumors (interval debulking surgery). The main goal is to see how long patients live without their cancer getting worse (progression-free survival) over 24 months. The study is currently recruiting about 114 participants.

Study design
This is a Phase 2, controlled, randomized, open-label study with about 114 participants, divided into a safety lead-in group and a randomized group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track progression-free survival for 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06504147

A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

Recruiting
PHASE2Ages 18+InterventionalPrevention
Oncoinvent Solutions AS
~114 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Radspherin

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 24 months

Conditions

Peritoneal Carcinomatosis
Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPeritoneal CarcinomatosisPrimary Peritoneal Cancer

Where it's being run

10 sites across 6 states
Spain4
United Kingdom2
Florida1
Belgium1
Italy1
Norway1

Who to contact

Anne-Kirsti Aksnes, PhD
[email protected]
004722183305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Serum bilirubin \< 1.5 x upper limit of normal (ULN), and
Aspartate transaminase and alanine transaminase ≤ 3 x ULN. 11. Adequate bone marrow function:
Absolute neutrophil count ≥ 1.0 x 10\^9/l, and
Platelets ≥ 100 x 10\^9/l, and
Haemoglobin ≥ 9 g/dL. 12. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment. 13. For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \< 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS.
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \< 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

What this trial measures

  • Progression free survival24 months

    To compare PFS in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer1 with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment.