Hepatocellular Carcinoma
Conditions
Interventions
medication administration team:CMD011 for injection
Sponsors
The first affiliated hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Has fully understood and voluntarily signed an informed consent form for this study and is willing and able to comply with study procedures. 2. Age = 18 years. 3. Histologically or cytologically confirmed unresectable/metastatic HCC. 4. Barcelona Clinic Liver Cancer (BCLC) stage B or C. Subjects with BCLC Stage B HCC must meet the criteria of being unable to receive surgical/local therapy or have progressed after surgical/local therapy or refuse surgical/local therapy. 5. Progress after at least one systemic therapy, regardless of the type of systemic therapy previously received. 6. Child-Pugh score = 7. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 8. Expected survival = 3 months. 9. At least one measurable lesion via RECIST v1.1 criteria with unequivocal imaging progression of the target lesion without or after prior radiation therapy. 10. Positive GPC3 expression demonstrated by immunohistochemistry (IHC) with the requirement of providing a testing report within the last 2 years, or the willingness to consent for the provision of tissue archives from the past 2 years for GPC3 expression testing. 11. Adequate organ function as detailed for full laboratory tests required for enrolled subjects (no blood components, cell growth factors, albumin, or other corrective therapeutic agents are allowed within 14 days prior to obtaining laboratory tests): Hematologic (no transfusion or hematopoietic stimulating factor treatment within 14 days) Neutrophils (ANC) = 1.0 x 10^9/L Platelets (PLT) = 50 x 10^9/L Hemoglobin (Hb) = 80 g/L Hepatic function Total bilirubin (TBIL) = 3.0 × ULN Alanine aminotransferase (ALT) = 5.0 × ULN Aspartate aminotransferase (AST) = 5.0 × ULN Renal function Creatinine = 1.5 × ULN; Or creatinine clearance (Ccr) = 60 ml/min (Ccr calculated according to Cockcroft-Gault formula only if creatinine > 1.5 × ULN) Urine protein = 2 +; Coagulation function Activated partial thromboplastin time (aPTT) = 1.5 × ULN International normalized ratio (INR) and prothrombin time (PT) = 1.5 × ULN 12. For hepatitis B virus (HBV) infected subjects, quantitative HBV DNA testing must be = 2000 IU/ml at screening. • For HBV DNA positive subjects, anti-HBV viral therapy must have been started at least 14 days prior to the start of study treatment. • For subjects with HBsAg (+) and/or HBcAb (+), anti-HBV viral therapy may be administered as necessary, as assessed by the investigator. 13. Anti-HCV therapy is required for hepatitis C virus (HCV) infected subjects if HCV RNA positive is detected. 14. Female subjects had evidence of postmenopausal status or a negative serum pregnancy test result for premenopausal female subjects. Women who have been amenorrheic for 12 months without other medical reasons are considered postmenopausal. Specific requirements for age are as follows: • Female subjects 1 year earlier, or had chemotherapy in
Exclusion criteria
Exclusion criteria: 1.Adverse reactions due to prior anticancer therapy have not recovered to grade = 1 by NCI-CTCAE v5.0 prior to enrollment (except alopecia or tolerable events due to anticancer therapy as judged by the investigator). 2.Imaging studies showed tumor thrombus invading the main portal vein, or the inferior vena cava/heart. 3.History or presence of hepatic encephalopathy. 4.History of hepatic surgery/local therapy (ablation therapy, absolute ethyl alcohol injection, etc) or radiotherapy within 4 weeks prior to the first dose. 5.Active or documented gastrointestinal bleeding (e.g., esophageal or gastric varices, ulcer bleeding) within 6 months. 6.Presence of ascites or clinical symptoms caused by ascites, or ascites requiring special treatment during the screening period, such as repeated drainage, or intraperitoneal infusion of drugs (Note: subjects with a small amount of ascites detected only by imaging examination can be included). Presence of uncontrolled pleural or pericardial effusion (clinical symptoms requiring repeated drainage, or intrapleural/intrapericardial instillation of drugs, etc.) during the screening period. 7.Presence of meningeal or central nervous system (CNS) metastases. 8.Primary malignancy other than HCC within 5 years. Excluded: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ who have been treated with curative intent and have not had disease relapse within 5 years prior to screening. 9.Use of other investigational agents for clinical trials within 4 weeks prior to the first study administration. 10.Autoimmune disease requiring systemic steroids (prednisone > 10 mg/day or equivalent) or immunosuppressive agents within 2 years prior to the first study dose. Exceptions: pituitary or adrenal insufficiency requiring thyroxine or physiologic corticosteroid replacement treatment. 11.Received herbal decoction or herbal preparation for anti-hepatocellular carcinoma indication within 14 days prior to the first dose. 12.Prior CAR-T cell therapy. 13.According to the New York Heart Association (NYHA) classification, the subject had clinically significant uncontrolled cardiovascular disease, including Class III and Class IV congestive heart failure ; myocardial infarction or unstable angina pectoris (within 6 months) ; uncontrolled hypertension (systolic blood pressure = 150 mmHg and diastolic blood pressure = 100 mmHg) ; clinically significant uncontrolled arrhythmias, including bradycardia that may cause QT prolongation (e.g., Class II or III heart block). Left ventricular ejection fraction (LVEF) 480 ms (corrected using Fridericia 's formula). 14.Had a clear history of interstitial lung disease or pneumonitis, except caused by local radiotherapy; active tuberculosis. 15.Serious acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy during the screening period, except: viral hepatitis. 16.Subjects who have undergone major surgery within 4 weeks prior to the first dose (central venous catheterization, biopsy, etc. are not considered major surgery). 17.Subjects with known human immunodeficiency virus (HIV) infection; subjects with active syphilis infection. 18.Lactating women. 19.Subjects who have received prior allogeneic stem cell or solid organ transplantation. 20.Subjects with a history of hypersensitivity or hypersensitivity to any component of the study drug. 21.Known psychiatric disorder or substance abuse d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(disease control rate);PFS(Progression Free Survival);OS(Overall Survival);PK(pharmacokinetics);ADA(Anti-drug antibody); | — |
Countries
China
Contacts
Public ContactLiang Tingbo
The first affiliated hospital, Zhejiang University School of Medicine
Outcome results
None listed