Clinical trial · Interventional
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
A Phase Ib, Open-Label Study Evaluating The Safety, Tolerability, and Pharmacokinetics of Onartuzumab Given as a Single Agent and in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
- 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)
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Onartuzumab | Drug | Onartuzumab | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 (Onartuzumab)
- interventionNames
- Drug: Onartuzumab
- type
- EXPERIMENTAL
- label
- Cohorts 2/3 (Onartuzumab + Sorafenib)
- interventionNames
- Drug: Onartuzumab
- Drug: Sorafenib
Primary outcomes (2)
- measure
- Number of Participants with Dose-limiting Toxicities (DLT)
- timeFrame
- Maximum up to 42 days
- measure
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Cytologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC) * Advanced or metastatic disease * Not a candidate for curative treatments (that is, resection, transplantation) * Child-Pugh class A liver function * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Life expectancy greater than (\>) 3 months * For participants who received prior adjuvant chemotherapy, a treatment-free interval of at least 6 months between the last chemotherapy cycle and Cycle 1 Day 1 Exclusion Criteria: * Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone * Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation * Granulocyte count less than (\<) 1500 per cubic millimeter (mm\^3), platelet count \< 75,000/mm\^3, and hemoglobin \< 8 gram per deciliter (g/dL) within 7 days prior to Cycle 1 Day 1 * Total bilirubin greater than (\>) 1.5 times the upper limit of normal (ULN) * Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase (ALP) \> 5 × ULN * Serum creatinine \> 1.5 × ULN or creatinine clearance \< 60 cubic centimeter per minute (cc/min) by Cockcroft-Gault formula * Significant history of cardiac disease within 6 months prior to Cycle 1 Day 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication * Serious active infection, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment, with the exception of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections * Known active infection with human immunodeficiency virus (HIV) or known HIV-seropositivity * Inability to take oral medication or untreated malabsorption syndrome * Pregnant or lactating women * History of transplantation including organ, bone marrow transplantation, and peripheral blood stem cell transplantation with the exception of corneal transplantation * Active bleeding diathesis (including active esophageal varices) or tumor rupture within 8 weeks prior to Cycle 1 Day1 that are not successfully treated * Uncontrolled hypertension * Treatment with any other investigational drug within 4 weeks of Cycle 1 Day
References
Publications (0)
Data not yet available