NEW YORK – Sotio Biotech said on Tuesday that it has dosed the first patient in a Phase I/II clinical trial of its antibody-drug conjugate SOT102 for gastric and pancreatic cancer patients.
The first in-human trial, dubbed CLAUDIO-01, is designed to evaluate the safety and preliminary efficacy of the Claudin-18.2 (CLDN18.2)-directed antibody drug conjugate as both a monotherapy and a combination treatment for up to 109 patients with gastric and pancreatic cancer. The trial will take place in Belgium, the Czech Republic, France, Spain, and the US.
Although Sotio will enroll patients into the trial regardless of their tumors' Claudin-18.2-expression levels, the firm will likely limit enrollment in later-phase trials to patients whose tumors are confirmed to be Claudin 18.2 positive, according to a spokesperson for Sotio. That will allow the firm to home in on an appropriate cutoff for the biomarker associated with treatment response and develop a companion diagnostic capable of detecting low levels of Claudin 18.2. The firm, headquartered in Prague and owned by the Czech Republic-based investment firm PPF Group, has not shared additional details on its diagnostic development plans.
The investigational drug, which Sotio is developing in collaboration with NBE Therapeutics, involves a monoclonal antibody linked to a cytotoxic molecule. According to the firm, preclinical data suggests potent anti-tumor efficacy.
"CLDN18.2 is a promising target in gastric and pancreatic cancer due to its prevalent expression in cancers of the gastrointestinal tract," Josep Tabernero, the head of medical oncology at Vall d'Hebron University Hospital in Barcelona and one of the investigators on the CLAUDIO-01 trial said in a statement. "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."