The purpose of this study is to evaluate the safety and tolerability of OMP-31M32 as a single agent or in combination with nivolumab. OMP-313M32 is an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR allowing the body's T-cells to destroy cancer cells.
This is an open-label, Phase 1a/b dose escalation study of OMP-31M32 administered as a single agent or in combination with nivolumab to evaluate the safety, tolerability pharmacokinetics, and pharmacodynamics in patients with locally advanced or metastatic solid 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 2 years. Subjects will be enrolled in two stages in the Phase 1a (dose escalation and expansion) and one stage in the Phase 1b (dose escalation).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.
Human IgG4 anti-PD-1 monoclonal antibody
Scottsdale
Scottsdale, Arizona, United States
Durham
Durham, North Carolina, United States
Oklahoma
Oklahoma City, Oklahoma, United States
Nashville
Nashville, Tennessee, United States
Salt Lake City
Incidence of dose limiting toxicities (DLTs)
The Maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-313M32 in combination with nivolumab
Time frame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Incidence of treatment emergent adverse events
Percentage of patients with adverse events
Time frame: up to approximately 2 years
Pharmacokinetic Outcome Measures (AUC) - Phase 1a
Area under the plasma concentration versus time curve (AUC) will be evaluated
Time frame: 1st dose and 4th dose: pre-dose, post-infusion, and 1, 3, 7 and 10 days. All other doses: pre-dose, 15 minutes and 7 days post-infusion. PK sample will be taken at treatment termination and every 4 wks for 12 wks.
Pharmacokinetic Outcome Measures (AUC) - Phase 1b
Area under the plasma concentration versus time curve (AUC) will be evaluated
Time frame: 1st dose and 4th dose: pre-dose and 15 minutes post-infusion. All other doses: pre-dose. PK sample will be taken at treatment termination and every 4 wks for 12 wks.
Pharmacokinetic Outcome Measures (T1/2) - Phase 1a
The half life (T1/2) of OMP-313M32 will be assessed
Time frame: 1st dose and 4th dose: pre-dose, post-infusion, and 1, 3, 7 and 10 days. All other doses: pre-dose, 15 minutes and 7 days post-infusion. PK sample will be taken at treatment termination and every 4 wks for 12 wks.
Pharmacokinetic Outcome Measures (T1/2) - Phase 1b
The half life (T1/2) of OMP-313M32 will be assessed
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Salt Lake City, Utah, United States
Time frame: 1st dose and 4th dose: pre-dose and 15 minutes post-infusion. All other doses, pre-dose.PK sample will be taken at treatment termination and every 4 wks for 12 wks.
Immunogenicity of OMP-313M32
Percentage of patients with anti-OMP-313M32 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: approximately 2 years