Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00966251

Enrollment

Registered

2009-08-26

Start date

2009-10-31

Completion date

2011-06-30

Last updated

2012-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hepatocellular Carcinoma

Keywords

Primary Hepatocellular Carcinoma

Brief summary

The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.

Interventions

DRUGCT-011

CT-011

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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 inhaled steroids 7. Presence of metastasis.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma	12 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026