Immune-Onc Therapeutics has initiated patient dosing in a Phase I clinical trial investigating IO-108, a novel antibody therapy for patients with advanced hepatocellular carcinoma (HCC). The first-in-human study marks a significant milestone in the company's development of innovative immunotherapy approaches for liver cancer treatment.
Study Design and Objectives
The open-label, dose-escalation Phase I trial will evaluate the safety, tolerability, and preliminary anti-tumor activity of IO-108 in patients with advanced HCC who have experienced disease progression following standard therapies. The study employs a traditional 3+3 dose-escalation design to determine the maximum tolerated dose and recommended Phase II dose.
Disease Background and Unmet Need
Hepatocellular carcinoma represents the most common form of primary liver cancer, accounting for approximately 75-85% of cases globally. Despite recent advances in targeted therapies and immunotherapy, the prognosis for advanced HCC remains poor, with a five-year survival rate of less than 20%.
Therapeutic Approach
IO-108 represents a novel therapeutic approach in HCC treatment. As a targeted antibody therapy, it is designed to enhance anti-tumor immune responses while potentially offering a more favorable safety profile compared to existing treatment options.
Clinical Implementation
The trial will enroll patients across multiple clinical sites in the United States. Participants will receive IO-108 through intravenous administration according to a predetermined dosing schedule. The study includes comprehensive safety monitoring and regular tumor assessment using RECIST 1.1 criteria.
Expert Perspective
"The initiation of this Phase I trial represents an important step forward in our commitment to developing innovative treatments for patients with advanced liver cancer," stated a senior executive from Immune-Onc Therapeutics. "IO-108's unique mechanism of action could potentially offer a new treatment option for patients who have limited therapeutic alternatives."
Safety and Monitoring
The trial incorporates rigorous safety monitoring protocols, including regular assessment of adverse events, laboratory parameters, and vital signs. An independent Data Safety Monitoring Board will oversee the study to ensure patient safety throughout the trial.
