OncoMatch/Clinical Trials/NCT06418659
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients
Is NCT06418659 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD-801 for advanced hepatocellular carcinoma.
Treatment: CD-801 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: locoregional therapy
Exception: except for the treatments after which the disease still progressed according to mRECIST
prior anticancer treatment with any locoregional therapies ... (within 4 weeks, or within 2 weeks in case of sorafenib) ... except for the treatments after which the disease still progressed according to mRECIST
Cannot have received: antiangiogenic targeted therapy
Exception: except for the treatments after which the disease still progressed according to mRECIST
prior anticancer treatment with any ... antiangiogenic targeted therapies ... (within 4 weeks, or within 2 weeks in case of sorafenib) ... except for the treatments after which the disease still progressed according to mRECIST
Cannot have received: immune checkpoint inhibitor
Exception: except for the treatments after which the disease still progressed according to mRECIST
prior anticancer treatment with any ... immune checkpoint inhibitors ... (within 4 weeks, or within 2 weeks in case of sorafenib) ... except for the treatments after which the disease still progressed according to mRECIST
Cannot have received: chemotherapy
Exception: except for the treatments after which the disease still progressed according to mRECIST
prior anticancer treatment with any ... chemotherapy (within 4 weeks, or within 2 weeks in case of sorafenib) ... except for the treatments after which the disease still progressed according to mRECIST
Cannot have received: radiation therapy
radiotherapy (within 3 weeks)
Cannot have received: traditional Chinese medicine
active traditional Chinese medicine (within 2 weeks)
Lab requirements
Blood counts
ANC >= 1.0×10^9/L, Platelets >= 30×10^9/L, Hemoglobin >= 8.5 g/dL, INR <= 2.3
Kidney function
creatinine <= 1.5 × ULN or calculated creatinine clearance >= 40 mL/min
Liver function
Albumin (ALB) >= 25 g/L, total bilirubin <= 5 × ULN, AST/ALT/ALP <= 10 × ULN
Inadequate liver function: Albumin (ALB) < 25 g/L, or total bilirubin > 5 × ULN, or AST, ALP, or ALT >10 × ULN. Inadequate renal function defined as creatinine >1.5 × ULN or calculated creatinine clearance < 40 mL/min. Absolute neutrophil count (ANC) < 1.0×10^9/L, or Platelets < 30×10^9/L, or Hemoglobin < 8.5 g/dL. International Normalized Ratio (INR) > 2.3.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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