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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

September 30, 2026

Conditions
Metastatic Colorectal Cancer (mCRC)
Interventions
DRUG

HNF4α 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."

Trial Locations (1)

200003

RECRUITING

Shanghai Changzheng Hospital,Naval Medical University, Shanghai

All Listed Sponsors
lead

Shanghai Changzheng Hospital

OTHER