RecruitingPhase 2NCT06504147

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

A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery

Sponsor

Oncoinvent Solutions AS

Enrollment

114 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Peritoneal Carcinomatosis

Summary

This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests Radspherin, a radioactive treatment delivered directly into the abdomen, in women with advanced ovarian, fallopian tube, or peritoneal cancer that is homologous recombination proficient (meaning the cancer cells can repair DNA damage, making them harder to treat with certain drugs). Patients receive this treatment alongside their standard surgery and chemotherapy. **You may be eligible if...** - You are a woman aged 18 or older with advanced high-grade ovarian, fallopian tube, or peritoneal cancer (Stage IIIB/C or IV) - Your cancer has been confirmed as HR-proficient by genetic testing - You have received chemotherapy (NACT) before planned surgery and your tumor is stable or shrinking - You are fit enough to undergo interval surgery and further treatment - Your kidney and liver function are adequate **You may NOT be eligible if...** - Your cancer has HR deficiency (certain genetic mutations that make it easier to treat with PARP inhibitors) - You have received prior cancer therapy that has not recovered in terms of side effects - You are unable to undergo debulking surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRadspherin

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.