Actively Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients
Led by Shanghai Changzheng Hospital · Updated on 2025-04-24
37
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of Intravenous CD-801 treatment in subjects with advanced hepatocellular carcinoma(HCC). Condition of disease: advanced hepatocellular carcinoma. Intervention： 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. The trial is structured in two phases: dose escalation and dose expansion. Dose Escalation Phase: The study employs a i3+3 design to assess escalating CD-801 dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day DLT observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety. Dose Expansion Phase: The expansion phase will use the safe dosage and regimen from the escalation phase, with treatments starting 14 ± 3 days after the initial dose, then every 28 ± 7 days, adjusted as needed. It ends upon complete response, disease progression, toxicity, withdrawal, loss to follow-up, new oncological treatments, or investigator termination, with a final assessment 14 days post-last dose. The phase plans to enroll about 10 participants to further assess CD-801's safety, tolerability, and antitumor effects using mRECIST. Drug: CD-801, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α. According to Amendment 1, in these two phases, 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.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by American Association for the Study of Liver Diseases criteria
- Unresectable HCC
- Not eligible for locoregional or systemic therapies, or had disease progression, or would not benefit after at least one conventional therapy
- At least 1 measurable target lesion according to mRECIST
- Life expectancy of 12 weeks or more
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Males with fertility and females of childbearing potential agree to use effective contraception during study and for 6 months after
- Females of childbearing age must have a negative pregnancy test within 7 days before first dose
- Willingness and ability to provide written informed consent and comply with study protocol
You will not qualify if you...
- Albumin (ALB) less than 25 g/L, or total bilirubin more than 5 times upper limit of normal (ULN), or AST, ALP, or ALT more than 10 times ULN
- Creatinine greater than 1.5 times ULN or creatinine clearance less than 40 mL/min
- Absolute neutrophil count less than 1.0 x10^9/L, platelets less than 30 x10^9/L, or hemoglobin less than 8.5 g/dL
- International Normalized Ratio (INR) greater than 2.3
- History of liver transplantation
- Poorly controlled hypertension, diabetes, serious heart or lung diseases, or serious dysfunction
- Extrahepatic metastasis without prior first-line systemic therapy or currently receiving effective systemic therapy
- Prior anticancer treatments within specified time frames before first dose, except if disease progressed per mRECIST
- Ongoing toxicities grade 2 or higher from prior treatments except hair loss or judged tolerable
- Recent serious complications like gastrointestinal hemorrhage, hepatic encephalopathy, or refractory ascites within 2 weeks before first dose
- Uncontrolled active infections
- History of other malignancies within 5 years except low-risk cancers
- HBV DNA greater than 500 copies/mL or HCV RNA greater than 15 U/mL
- Positive for HIV
- Allergy to MRI contrast agents
- Pregnant or lactating women or women who may become pregnant
- Participation in other investigational drug trials within 4 weeks prior to study
- Any medical or other condition that precludes participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
C
CHUAN YIN, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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