Oncoinvent Expands Phase 2 Trial Sites for Radspherin Radiopharmaceutical in Ovarian Cancer
核心洞察
Oncoinvent (搜索) has activated four additional clinical sites for its Phase 2 trial of Radspherin® in patients with peritoneal carcinomatosis (搜索) from ovarian cancer (搜索), with the first patient enrolled at a newly activated site.
The randomized controlled trial is comparing progression-free survival between patients receiving Radspherin® after complete surgical resection following pre-operative chemotherapy versus patients receiving pre-operative chemotherapy and surgery alone.
The study will recruit patients across 11 sites in six countries, with positive Phase 1/2a safety data showing Radspherin® was well tolerated with no dose-limiting toxicity at the recommended 7MBq dose.
Oncoinvent (搜索), a clinical-stage radiopharmaceutical company, announced the expansion of its Phase 2 trial for Radspherin® with the activation of four additional recruitment sites and enrollment of the first patient at one of these newly activated locations. The trial is evaluating the investigational radiopharmaceutical in patients with peritoneal carcinomatosis (搜索) from ovarian cancer (搜索).
Trial Expansion and Patient Enrollment
The randomized portion of the Phase 2 study has been actively recruiting patients at six sites since March 2025. With the addition of four new sites, the trial now operates across a total of 11 locations spanning Norway (1), Spain (5), Belgium (1), the United Kingdom (2), the United States (1), and Italy (1).
"The process of opening new clinical sites involves extensive regulatory reviews, contracting, and site-readiness work. We are therefore pleased to see both the successful activation of additional sites and the enrollment of the first patient at a newly onboarded site," said Kari Myren, Chief Medical Officer at Oncoinvent (搜索).
Study Design and Objectives
The Phase 2 trial (ClinicalTrials.gov: NCT06504147) is a randomized controlled study assessing the efficacy and safety of Radspherin® in patients with peritoneal metastases from ovarian cancer (搜索). The primary objective compares progression-free survival (PFS) between two treatment arms: patients receiving Radspherin® after complete surgical resection following pre-operative chemotherapy, versus patients receiving pre-operative chemotherapy and surgery alone.
Safety Profile and Previous Results
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. According to Oncoinvent (搜索), early clinical efficacy data are highly encouraging, and no serious toxicity or safety concerns have been reported to date across completed Phase 1 and Phase 1/2a trials.
Radiopharmaceutical Technology
Radspherin® represents an investigational radiopharmaceutical designed for local treatment of cancer that has spread to body cavities. The therapy consists of billions of calcium carbonate microparticles containing the radioactive material radium-224 (搜索). The mechanism of action involves the decay of radium-224 emitting alpha-particles, described as a highly potent form of ionizing radiation.
The treatment is administered intraperitoneally following surgical resection with removal of all macroscopic disease, directly targeting micro-metastases post-surgery. This approach harnesses the benefits of modern radiopharmaceuticals without the complexities of biological targeting, according to the company.
Clinical Development Program
Oncoinvent (搜索) is investigating Radspherin® in a clinical development program covering two indications, with studies targeting peritoneal carcinomatoses from both ovarian and colorectal cancer (搜索). The company has completed one Phase 1 trial and one Phase 1/2a trial, with the current randomized Phase 2 trial ongoing in the US and Europe.