Oncoinvent has initiated a Phase 2 clinical trial for Radspherin, a novel alpha-radiation therapy, in patients with peritoneal carcinomatosis originating from ovarian cancer. The first patient has been dosed in this randomized, controlled study designed to evaluate the efficacy and safety of Radspherin in improving progression-free survival (PFS). This milestone follows promising Phase 1/2a trial results and a recent Fast Track designation from the U.S. Food and Drug Administration (FDA). The trial is being conducted across six centers in Belgium, Norway, Spain, the UK, and the US.
Radspherin's Mechanism of Action
Radspherin leverages billions of calcium carbonate microparticles to deliver radium-224 directly to cancerous areas within body cavities. Its mechanism relies on the targeted application of alpha particles, known for their potent radiation effects. The treatment is administered intraperitoneally after the surgical removal of visible tumors, offering a targeted approach to cancer therapy.
Trial Design and Objectives
The Phase 2 trial (NCT06504147) is designed to assess the efficacy and safety of Radspherin in patients with peritoneal metastasis from ovarian cancer. The primary objective is to compare PFS between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy and patients who only undergo pre-operative chemotherapy and surgery.
Prior Clinical Data
Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well-tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.
Management Commentary
"We are pleased to announce the dosing of the first patient in our Phase 2 study of Radspherin in ovarian cancer patients, representing another pivotal achievement that underscores the potential of our clinical programme," said Oystein Soug, Chief Executive Officer of Oncoinvent. "This milestone builds upon the highly encouraging data from our Phase 1/2a trials in ovarian and colorectal cancer patients, where Radspherin demonstrated promising safety and efficacy. This follows the FDA’s recently granted Fast Track designation, bringing us closer to demonstrating the therapeutic potential of Radspherin. We look forward to advancing this clinical study as part of our mission to improve outcomes for patients suffering from peritoneal carcinomatosis."
