On October 10, 2024 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been dosed in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer (Press release, Oncoinvent, OCT 10, 2024, View Source [SID1234647148]). Radspherin is a novel alpha-radiation therapy candidate designed for targeted, local treatment of cancers that have spread to body cavities. The Phase 2 trial is a randomized controlled study designed to assess progression-free survival (PFS) in primary advanced ovarian cancer patients treated with Radspherin following complete surgical resection and pre-operative chemotherapy.
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"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 program," 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."
The Phase 2 trial (NCT06504147) is a randomized controlled study assessing 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. The study is being conducted at six centers in the US, UK, Norway, Spain and Belgium. 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.