The trial will analyse Radspherin to treat peritoneal carcinomatosis from ovarian cancer. Credit: aslysun / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted clearance for Oncoinvent’s investigational new drug (IND) application to commence the Phase II clinical trial of Radspherin to treat ovarian cancer associated peritoneal carcinomatosis. 

Oncoinvent plans to commence the trial in the second quarter of next year.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

The controlled, randomised trial will evaluate the safety and efficacy of Radspherin. 

Comparison of progression-free survival (PFS) in Radspherin-treated patients following full surgical resection subsequent to pre-operative chemotherapy, as well as those undergoing pre-operative chemotherapy and surgical procedures, will be the primary objective of the trial.

In a Phase I trial of Radspherin in patients with recurrent ovarian cancer, the company chose a recommended 7MBq dose of the therapy. 

In addition, interim safety data showed that Radspherin was well tolerated and no dose-limiting toxicity was reported.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Oncoinvent CEO Anders Månsson said: “We are thrilled to announce the IND clearance for this Phase IIb study of Radspherin, allowing for inclusion of patients in the first-line treatment setting of ovarian cancer. 

“This IND clearance comes in succession to the IND clearance of Radspherin in colorectal cancer patients, announced recently. 

“With the initiation of two US clinical trials, we look forward to broadening the clinical reach of Radspherin to include both US and Europe.” 

Prior to this, the company received IND clearance from the FDA to assess Radspherin for peritoneal carcinomatosis from colorectal cancer.