The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
This is an open-label, Phase 1a dose escalation study of OMP-336B11 administered as a single agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic tumors. This study consists of a screening period, a treatment period, and a post-treatment follow-up period in which patients will be followed for survival for up to approximately 2 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
Incidence of dose limiting toxicities (DLTs)
Time frame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Pharmacokinetic Outcome Measures (CL)
Clearance (CL) will be evaluated
Time frame: Screening through 12 weeks post treatment termination
Pharmacokinetic Outcome Measures (Vd)
Volume of distribution (Vd) will be evaluated
Time frame: Screening through 12 weeks post treatment termination
Pharmacokinetic Outcome Measures (T1/2)
The half life (T1/2) of OMP-336B11 will be assessed
Time frame: Screening through 12 weeks post treatment termination
Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)
Percentage of patients with anti-336B11 antibodies assessed
Time frame: up to approximately 2 years
Objective Response
Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to approximately 2 years
Progression-Free Survival
Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: up to approximately 2 years
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