On September 28, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that the trial Safety Monitoring Committee approved its first-in-human Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to progress to the fourth level dose cohort (Press release, Oncoinvent, SEP 28, 2021, View Source [SID1234590413]). Enrollment in this cohort, where patients will receive 7 MBq of Radspherin, is expected to begin imminently.
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"The progression of the RAD-18-001 study to the fourth dose level, continues to build our confidence as we continue to develop Radspherin for treatment peritoneal carcinomatosis, an area of high unmet need," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "we will now start dosing patients at the 7 MBq dose level, a dose level that has been found to be safe in colorectal cancer patients."
About RAD-18-001
The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.
About Radspherin
Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.