RecruitingEarly Phase 1NCT06621173

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

A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer


Sponsor

Shanghai Changzheng Hospital

Enrollment

9 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment — a combination of immune checkpoint inhibitor drugs given directly into tumors through a minimally invasive procedure — for people with advanced colorectal cancer that has stopped responding to standard treatments. The goal is to see if this approach can help patients whose cancer has not responded to previous therapies. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that has spread or cannot be removed surgically - You have already tried standard chemotherapy (fluorouracil, oxaliplatin, or irinotecan) and targeted drugs, and your cancer has progressed - Your tumor has specific genetic features (dMMR or MSI-H) and has also progressed after immune checkpoint therapy (anti-PD-1 or anti-PD-L1) - You have acceptable organ function **You may NOT be eligible if...** - You have not yet tried standard treatments - Your cancer does not have the required genetic features - You have severe liver, kidney, or blood count problems 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.

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Interventions

DRUGHNF4α srRNA

HNF4α srRNA will be administered intravenously for the treatment of metastatic colorectal cancer. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA administered via peripheral vein for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or colorectal cancer. Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment.


Locations(1)

Shanghai Changzheng Hospital,Naval Medical University

Shanghai, Shanghai Municipality, China

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NCT06621173


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