A Multi-Center, Open-Label, Single-Arm, Phase 2 Study of ASONEP™ (Sonepcizumab/LT1009) Administered as a Single Agent to Subjects With Refractory Renal Cell Carcinoma
LT1009-Onc-002 is a Phase 2a open-label, multi-center study designed to evaluate the
efficacy and safety of ASONEP (sonepcizumab/LT1009) monotherapy in subjects with advanced,
unresectable, refractory RCC who have previously failed up to 3 therapies, including VEGF
and/or mTOR inhibitors. Two cohorts will be enrolled for a total of up to 39 subjects.
Subjects will receive an intravenous (IV) infusion of ASONEP™ over 90 minutes at 15 mg/kg
once a week and progression-free survival (PFS) will be assessed after 8 weeks of treatment.
Cohort 1 will enroll approximately 22 subjects. A second cohort of up to 17 subjects will be
enrolled if at least 12 out of 22 subjects from Cohort 1 demonstrated PFS at 8 weeks. Weekly
dosing will take place from the date of randomization until the date of first documented
progression or date of death from any cause, whichever comes first.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The study will use a two-cohort design based on an 8-week PFS rate. Treatment will be considered promising if at least 12 out of the first 22 eligible subjects entered in the Cohort 1 of the study are progression free at Week 8. Enrollment of Cohort 2 will then proceed and be considered worthy of further evaluation if at least 25 out of 39 eligible subjects are progression free at Week 8. If no efficacy signal is observed after enrollment of 22 subjects in Cohort 1, the second cohort will not be enrolled and the clinical study may be stopped.
Executive Director of Development at Lpath
United States: Food and Drug Administration
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Tennessee Oncology||Nashville, Tennessee 37203|