SOT102 along with combination therapies is intended for the treatment of gastric and pancreatic cancer. Credit: PopTika / Shutterstock.

SOTIO Biotech has dosed the first patients in the combination therapy arms of Phase I/II CLAUDIO-01 trial evaluating SOT102 for treating gastric and pancreatic cancer.

The first-in-human, multicentre, open-label study is being carried out at centres in Europe and the US.

It will assess the preliminary efficacy and safety of SOT102 along with the current standard of care as a first-line cancer treatment.

SOT102 will be evaluated in combination with mFOLFOX plus nivolumab in the gastric cancer arm, while in the pancreatic cancer arm, it will be assessed along with Nab-paclitaxel and gemcitabine.

To date, no dose-limiting toxicities were reported during the study.

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SOTIO Biotech CEO Radek Spisek said: “The initiation of the combination arms in our Phase I/II CLAUDIO-01 trial represents an exciting clinical milestone in the development of SOT102 and our pursuit to provide novel and improved treatment options for patients suffering from solid tumours.

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“The opportunity to evaluate SOT102 as part of a first-line treatment regimen will provide us valuable insights that could greatly expand the patient population who could benefit from this therapy.

“We look forward to collaborating with our clinical sites to carry out these studies as we work to deliver immunotherapies that can make a meaningful difference in the lives of patients with solid tumours.”

The company is advancing dose-finding studies in the trial’s monotherapy arm, where SOT102 will be used further in treating later-stage cancers.

SOT102 is an antibody-drug conjugate that combines target Claudin 18.2 with a powerful toxin to treat pancreatic, gastric and other cancers.