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Monoclonal Antibodies

Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

Phase 1 & 2
Waitlist Available
Led By Adam C Yopp, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months of patient enrollment (phase 1)
Awards & highlights
No Placebo-Only Group

Summary

This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.

Eligible Conditions
  • Hepatocellular Carcinoma
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months of patient enrollment (phase 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months of patient enrollment (phase 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median Radiographic Time to Progression (TTP) Calculated From Treatment Initiation to First Evidence of Disease Progression or Last Follow-up.
Number of Patients With Dose Limiting Toxicity
Secondary study objectives
Advance Directives
Median Months of Overall Survival Calculated From Treatment Initiation to Death or Last Follow-up.
Safety, as Measured by the Number of Patients With Adverse Event Related to the Treatment That Experienced Grade 3 or Greater.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice dailyExperimental Treatment1 Intervention
Cohort 1: Participants were administered Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
Group II: Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice dailyExperimental Treatment1 Intervention
Cohort 3: Participants were administered Bavituximab:3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Group III: Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice dailyExperimental Treatment1 Intervention
Cohort 2: Participants were administered Bavituximab:1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Bavituximab
Not yet FDA approved
Bavituximab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,615 Total Patients Enrolled
8 Trials studying Hepatocellular Carcinoma
928 Patients Enrolled for Hepatocellular Carcinoma
Adam C Yopp, MDPrincipal InvestigatorUT Southwestern Medical Center
~3 spots leftby Dec 2025
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