RecruitingEarly Phase 1NCT07050394

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

A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer


Sponsor

Shanghai Changzheng Hospital

Enrollment

20 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, open-label, exploratory clinical trial. Building on the previous dose-escalation trial, this dose-expansion trial aims to evaluate the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer, and to preliminarily explore its efficacy in treating colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an experimental gene-based therapy called HNF4α srRNA, given by IV infusion, in people with colorectal cancer that cannot be surgically removed or has spread to other organs, and who have already tried standard treatments. **You may be eligible if:** - You are 18 or older and have colorectal cancer confirmed by biopsy - Your cancer is unresectable (cannot be surgically removed) or metastatic - You have already tried standard chemotherapy and/or targeted treatments, or cannot tolerate them - Your cancer is measurable on imaging scans - You have adequate blood counts and organ function - You have a life expectancy of at least 12 weeks - You are willing to use effective contraception **You may NOT be eligible if:** - You have brain metastases - You have a bowel obstruction, perforation, or active bleeding - You have severe kidney, liver, or heart disease - You have an active autoimmune disease or are on immunosuppressants - You have received anticancer treatment within the past 4 weeks - You are HIV positive, or have active hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCD-GA-102

CD-GA-102 will be administered intravenously at 50 μg per dose, with dosing scheduled at 2 weeks (±3 days) and 4 weeks (±3 days) after the initial dose, followed by maintenance therapy every 3 weeks (±3 days). Dosing intervals may be adjusted based on participant tolerability and safety. After receiving at least two doses of CD-GA-102 monotherapy and completing safety assessments, participants may be offered combination therapies, as determined by the investigator.


Locations(1)

Shanghai Changzheng Hospital

Shanghai, None Selected, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07050394


Related Trials