A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 12, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

December 31, 2026

Conditions
Advanced Hepatocellular Carcinoma
Interventions
DRUG

CD-801

"CD-801 will be administered intravenously for the treatment of HCC. 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, patients who have received at least 4 cycles of HNF4α srRNA (CD-801 or CD-GA-102) therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per mRECIST criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy."

Trial Locations (1)

200003

RECRUITING

Changzheng Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Changzheng Hospital

OTHER