Study of Intravenous CD-801 Treatment for Adults With Advanced Liver Cancer Hepatocellular Carcinoma Evaluating Safety, Tolerability, and Effectiveness

What this Trial Is About

This clinical trial investigates the safety, tolerability, and effectiveness of intravenous CD-801 in adults with advanced hepatocellular carcinoma HCC, a common form of liver cancer. The study explores a new drug designed to target liver cancer cells and help restore a key protein, HNF4b1, which is important for liver cell function and may influence cancer growth. The trial is open-label and single-arm, aiming to improve treatment options for patients with advanced HCC who have limited current therapies. The study is conducted in two phases dose escalation and dose expansion. During the dose escalation phase, participants receive increasing doses of CD-801 25, 50, or 100 bcg intravenously to assess safety and determine the best dose. The dosing schedule includes a second dose about 14 days after the first, followed by doses every 28 days, adjusted based on patient tolerance and response. In the dose expansion phase, about 10 participants will receive the selected safe dose under the same schedule, with treatment continuing until disease progression, toxicity, withdrawal, or other criteria. Patients who have undergone prior cycles of the related therapy may continue or adjust their dose combined with other cancer treatments. Participants will receive CD-801 through a peripheral vein and undergo regular assessments including tumor measurements using mRECIST criteria to evaluate response. Safety and tolerability are closely monitored throughout the study, with follow-up assessments 14 days after the last dose. The primary outcomes include safety evaluation and the objective response rate to treatment. Secondary measures include duration of response, progression-free survival, overall survival, and other tumor response rates. The total participation time varies depending on individual response and study progression, with assessments continuing up to 24 months or longer for survival monitoring.

A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients