Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
1. Subjects aged 18 years and above, both genders.
2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
3. No fibrolamellar subtype HCC
4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC
5. Not eligible for Transarterial chemoembolization (TACE ).
6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA)
that were used for HCC, are permitted.
7. Not a candidate for curative surgical resection or liver transplantation
8. Measurable disease defined by the identification at least 1 measurable lesion by
MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging
post-procedure to be considered measurable disease.
9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
10. Child's Pugh classification A
11. ECOG performance status 0-1
1. Patients progressing to liver failure.
2. No core biopsy within the past 7 days
3. Patients who are eligible for Transarterial Chemoembolization (TACE)
4. Patients on concurrent anti-neoplastic therapy (including interferon)
5. Patients who have received any systemic anti-neoplastic therapy not approved for the
treatment of HCC.
6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or
7. Presence of metastasis.