Evaluating Safety and Effectiveness of Intravenous HNF4b1 SrRNA for Adults With Metastatic Colorectal Cancer

What this Trial Is About

Researchers are exploring the safety and tolerability of intravenous HNF4 srRNA injections in patients with colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. This early-phase clinical trial also aims to gather preliminary information about how well this treatment might work for metastatic colorectal cancer. The study focuses on patients who have limited treatment options due to disease progression or intolerance to standard therapies. Participants will receive HNF4 srRNA through intravenous injections, with the second dose given about two weeks after the first, followed by treatments every four weeks. The dose may be adjusted based on patient response and side effects, starting from one of three dose levels 25, 50, or 100 micrograms. Some patients initially receiving only HNF4 srRNA may later receive immunotherapy alongside this treatment, depending on their medical history and safety assessments. During the study, patients will be monitored for safety and treatment effects for about two years. Researchers will assess tumor response using imaging criteria and measure patient-reported outcomes and tumor biomarkers in the blood. Regular evaluations will include physical exams, laboratory tests, and safety assessments. The study will also track overall survival and how long any positive treatment responses last, providing important information about the treatments impact over time.

A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients