Clinical trial · Interventional
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
NCT00712855CI-TRIAL-00008363HCCcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mapatumumab | Biological | — | UNRESOLVED |
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- mapatumumab and sorafenib
- interventionNames
- Biological: mapatumumab
- Drug: sorafenib
Primary outcomes (1)
- measure
- Type, frequency, and severity of adverse events.
- timeFrame
- Until disease progression or unacceptable toxicity develops
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.