Oncoinvent ASA has reached a significant milestone in its clinical development program with the completion of patient recruitment for the safety lead-in cohort of its Phase 2 trial investigating Radspherin®, a pioneering alpha-radiation therapy for peritoneal metastases.
The randomized, open-label, multicenter trial (NCT06504147) is designed to evaluate the efficacy and safety of Radspherin® in patients with peritoneal metastases from ovarian cancer who have undergone complete surgical resection and pre-operative chemotherapy.
Trial Design and Progress
The initial safety lead-in phase specifically focuses on assessing the safety and tolerability of Radspherin® at the recommended dose of 7 MBq in the trial population. This evaluation is crucial before proceeding with the broader randomized portion of the study. The trial has successfully established an international presence, with participating centers across the United States, United Kingdom, European Union, and Norway.
"The completion of patient recruitment in the safety lead-in marks an important milestone in the advancement of our Phase 2 trial," said Oystein Soug, CEO of Oncoinvent. "We are encouraged by being able to recruit patients and ship Radspherin® to centers in the US, UK, EU as well as Norway in this trial."
Innovative Treatment Approach
Radspherin® represents a novel approach to treating cavity-spread cancers, utilizing targeted alpha-radiation therapy. The treatment is specifically designed to target micro-metastases post-surgery, leveraging the benefits of modern radiopharmaceuticals while avoiding the complexities typically associated with biological targeting methods.
Clinical Development Program
The current clinical program encompasses two Phase 1/2a trials and one randomized Phase 2 trial, with plans to enroll more than 150 patients suffering from peritoneal carcinomatosis secondary to ovarian and colorectal cancer. Early clinical efficacy data has shown promising results, with no serious toxicity or safety concerns reported to date.
Next Steps
The company plans to analyze the safety data from the lead-in cohort and announce findings during March. Following this analysis, Oncoinvent expects to proceed with full trial enrollment, marking another crucial step in developing Radspherin® as a potential treatment option for patients with peritoneal carcinomatosis.
"This milestone further reinforces our commitment to developing Radspherin® as a promising treatment option for patients with peritoneal carcinomatosis," added Soug, emphasizing the company's dedication to advancing this innovative therapeutic approach.
