A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

A Phase 1B, Multi-center, Open Label, Dose Escalation Study of Mapatumumab ([HGS1012], a Fully-human Monoclonal Antibody to TRAIL-R1) in Combination With Sorafenib as a First Line Therapy in Subjects With Advanced Hepatocellular Carcinoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712855

Acronym

HCC

Enrollment

Registered

2008-07-10

Start date

2008-06-30

Completion date

2012-08-31

Last updated

2012-10-30

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

Conditions

Hepatocellular Carcinoma

Keywords

Liver Cancer

Brief summary

The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface antigen or hepatitis C antibody.

Interventions

BIOLOGICALmapatumumab

3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle

DRUGsorafenib

400 mg orally, twice a day continuously in each cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderate liver disease * Test positive for hepatitis B surface antigen or hepatitis C antibody * Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma * Age 18 years or older

Exclusion criteria

* Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma. * Received radiation therapy within 4 weeks before randomization * Major surgery within 4 weeks before randomization * Minor surgery within 2 weeks before randomization * Systemic steroids within 1 week before randomization * Hepatic encephalopathy, per the investigator's evaluation * History of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment * History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization * Known brain or spinal cord metastases * History of other cancers within 5 years before enrollment * Pregnant or breast-feeding women * Known HIV infection

Design outcomes

Primary

Measure	Time frame
Type, frequency, and severity of adverse events.	Until disease progression or unacceptable toxicity develops

Countries

United States

Outcome results

None listed

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