Exploring Safety and Effectiveness of Intravenous HNF4B1 srRNA Treatment in Adults With Unresectable or Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and preliminary efficacy of intravenous CD-GA-102, a self-replicating RNA therapy, alone or combined with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer. This early phase 1, single-arm, open-label trial builds on prior dose-escalation results to explore treatment effects in this patient population. CD-GA-102 will be given through peripheral intravenous injection at 50 micrograms per dose, with the second dose administered about 2 weeks after the first and the third dose about 4 weeks after the first. Following these initial doses, maintenance therapy will be given every 3 weeks, with dosing intervals adjusted based on individual safety and response. After at least two doses and safety evaluation, participants may receive combination treatment with immune checkpoint inhibitors, targeted therapy, or other systemic drugs as decided by the investigator. Participants will be monitored through clinical assessments, imaging, and laboratory tests over approximately 2 years to evaluate tumor response using RECIST v1.1 criteria and to observe safety and tolerability. Key measures include objective response rate, duration of response, progression-free survival, overall survival, disease control, and patient-reported outcomes. This study aims to provide detailed safety and early efficacy data for this novel treatment approach in colorectal cancer.

A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer