The CDH17-targeting antibody-drug conjugate received the designation for previously treated advanced unresectable or metastatic colorectal cancer.
The FDA has granted fast track designation to the investigational antibody-drug conjugate (ADC) SOT109 for the treatment of patients with advanced unresectable or metastatic colorectal cancer (CRC) who have exhausted standard treatment options.¹
SOT109 targets CDH17, an antigen expressed in more than 90% of CRC cases and broadly across gastrointestinal malignancies. SOTIO expects to initiate a phase 1/2 trial (NCT07693751) of SOT109 in patients with advanced unresectable or metastatic CRC in the third quarter of 2026.
"Advanced CRC remains an area of profound unmet need, particularly for patients whose disease has progressed after standard therapies," Vivi Boura, MD, chief medical officer of SOTIO Biotech, stated in a news release. “SOT109 is designed to capitalize on the unique biology of CDH17, a highly prevalent target that is broadly and consistently expressed across colorectal tumors, while having limited expression in healthy tissues.”
The first-in-human, international, open-label phase 1/2 trial will evaluate the safety, pharmacokinetics, and preliminary efficacy of SOT109 in patients with advanced unresectable or metastatic CRC.2 Eligible patients must be at least 18 years old, have an ECOG performance status of 0 or 1, have a life expectancy of at least 3 months, have measurable disease via RECIST 1.1 criteria, and have adequate laboratory values. Patients must have also experienced disease progression on standard systemic therapies and have no further standard treatment options.
In part A, patients will receive SOT109 at 1 of 5 dose levels; the agent will be administered intravenously once every 21 days over 30 (±15) minutes. In part B, SOT109 will be given at the same dosing schedule at 2 dose levels recommended for optimization.
The primary end point in part A will be to determine the maximum tolerated and recommended phase 2 doses of SOT109. The primary end points in part B are determining the optimal dose of SOT109 for subsequent clinical trials, objective response rate per RECIST 1.1 criteria, and duration of response per RECIST 1.1 criteria. Secondary end points include safety and tolerability, pharmacokinetic measures, and progression-free survival.
“We believe fast track designation underscores both the urgent need for new treatment options and the potential of SOT109 to expand the benefits of targeted ADC therapy to a substantially broader patient population," Boura added in the news release.1
