Actively Recruiting
Phase 2 Study of Radspherin Injection for Women With Advanced High-Grade Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Scheduled for Chemotherapy and Surgery
Led by Oncoinvent Solutions AS · Updated on 2026-05-20
114
Participants Needed
10
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a single intraperitoneal injection of Radspherin4 in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer that has spread within the peritoneal cavity. This Phase 2, randomized, open-label, multicenter study focuses on patients whose tumors are homologous recombination proficient and who are scheduled for neoadjuvant chemotherapy NACT followed by interval debulking surgery IDS aiming to remove all visible tumors R0 resection. The study includes a safety lead-in phase followed by a randomized treatment phase, with the same procedures and assessments for all participants. Participants will receive either Radspherin, which is a suspension of biodegradable calcium carbonate microparticles containing the alpha-emitting radionuclide 224Ra, or no additional intervention in the control group. The radionuclide has a physical half-life of 3.6 days. Both groups will undergo NACT and IDS as planned. The study is divided into two parts an initial safety lead-in cohort, then a randomized phase comparing Radspherin versus control. Throughout the study, participants will be monitored for progression-free survival up to 24 months as the primary outcome. Additional assessments will include peritoneal progression-free survival and safety evaluations. Patients will have regular clinical assessments, imaging, and laboratory tests to evaluate disease status and treatment effects. The study will continue until February 2031, with ongoing follow-up to track outcomes and safety.
CONDITIONS
Brief Title
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
Research Team
A
Anne-Kirsti Aksnes, PhD
T
Trine Jensen Gjertsen
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