Launching of Early-Phase Trial May Mark a ‘Major Milestone’ for Improving Gastric and Pancreatic Cancer Treatment


The first patient was dosed in the CLAUDIO-01 trial, analyzing SOTO102 in patients with certain types of gastric and pancreatic cancers.

The first patient has been dosed in the ongoing phase 1/2 CLAUDIO-01 clinical trial examining a new antibody drug conjugate called SOT102 in patients with gastric and pancreatic cancer, according to SOTIO, the manufacturer of the drug.

Antibody drug conjugates work by targeting specific markers found on cancer cells. In this case, SOTO102 targets CLDN18.2, a molecule found on many gastric cancers.

“Antibody-drug conjugates constitute one of the most exciting drug classes in oncology,” said Dr. Radek Spisek., chief executive officer of SOTIO, in a press release. “The careful design of SOT102, including the use of NBE-Therapeutics’ (antibody drug conjugate) platform is aimed to provide an efficacious and safe treatment option for patients with CLDN18.2 cancers.”

The CLAUDIO-01 trial will be open-label (meaning that both the clinicians and the patients know what treatments are being administered) geared toward analyzing the safety and preliminary efficacy of SOTO102 alone, as well as in combination with previously established standard-of-care treatment options.

The first-in-human trial will be conducted in multiple cancer treatment centers around the world, (in Belgium, the Czech Republic, France, Spain and the United States) and researchers plan on enrolling up to 109 patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma.

“CLDN18.2 is a promising target in gastric and pancreatic cancer due to its prevalent expression in cancers of the gastrointestinal tract. Based on its preclinical data SOT102 represents a potentially safer and more effective treatment option for targeting the CLDN18.2 protein in gastric and pancreatic cancers. The initiation of this clinical trial is major milestone in studying its potential benefit for these patients,” said Dr. Joseph Tabernero, Head of Medical Oncology at Vall d’Hebron University Hospital and coordinating investigator of the trial, in the release.

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