The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Angiogenesis plays a central role in the progression of epithelial ovarian cancer. In mouse models, VEGF-inhibitors diminish ovarian tumor growth, metastasis and malignant ascites formation. Independent Phase 2 trials have demonstrated single-agent activity for bevacizumab in recurrent ovarian cancer, and randomized controlled Phase 3 trials are ongoing in the first-line setting (GOG 0218 and ICON-7) and for recurrent disease (GOG 0213, OCEANS). TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on vascular endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. In a Phase 1 study of advanced solid tumors, TRC105 therapy caused a global reduction in angiogenic biomarkers and reduced tumor burden at doses that were well-tolerated. We hypothesize that TRC105 will have single-agent activity in recurrent ovarian cancer. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibitors which could represent a major advance in ovarian cancer therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Progression-free Survival Rate After 6 Months of Treatment on Study
Number of patients ongoing within the study who have not progressed after 6 months of treatment
Time frame: 6 months
Proportion of Patients Who Have Objective Tumor Response
Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Time frame: Every 2 cycles
Adverse Events
Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
Time frame: 28 days
CA-125 Response Rate
CA-125 response rate by GCIG criteria
Time frame: Every 2 cycles
Serum Concentrations of TRC105
Median peak and trough concentration of TRC105 by ELISA in ug/mL
Time frame: Cycle 1 Day 15
TRC105 Immunogenicity
TRC105 Anti-Drug Antibody (ADA) Immunogenicity by ELISA
Time frame: 1 year
Severity of Adverse Events
Severity of adverse events by NCI CTCAE
Time frame: 28 days post last dose of TRC105
Overall Survival
Median overall survival
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Indiana University-Bren and Melvin Simon Cancer Center
Indianapolis, Indiana, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States