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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs Radspherin (Primary)
  • Indications Cancer metastases; Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Therapeutic Use
  • Sponsors Oncoinvent

Most Recent Events

  • 25 Mar 2025 According to Oncoinvent Media Release, the safety data from the patients in the safety lead-in cohort of its ongoing Phase 2 trial evaluating Radspherin for the treatment of peritoneal carcinomatosis from ovarian cancer has been reviewed by the company and study investigators. No safety concerns were identified, and based on this review, the company is pleased to confirm that the randomized part of the trial is now initiated, with the first patient successfully enrolled.
  • 27 Feb 2025 According to Oncoinvent Media Release, an interim analysis is planned 9 months after enrolment of the last patient. The trial will be conducted at 6 centers, where new sites in the UK and in the US have been initiated in addition to the sites that were involved in the phase 1 trial in ovarian cancer in Norway, Belgium and Spain.
  • 27 Feb 2025 According to Oncoinvent Media Release, the company announced the successful enrollment of the sixth patient into the safety lead-in cohort of its ongoing Phase 2 trial evaluating Radspherin for the treatment of peritoneal carcinomatosis from ovarian cancer.

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