Spots Global Cancer Trial Database for A Study of OMP-313M32 in Subjects With Locally Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: A Study of OMP-313M32 in Subjects With Locally Advanced or Metastatic Solid Tumors

Official Title: A Phase 1a/b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of OMP-313M32 Administered as a Single Agent or in Combination With Nivolumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Study ID: NCT03119428

Conditions

Locally Advanced Cancer

Metastatic Cancer

Interventions

OMP-313M32

Nivolumab

Study Description

Brief Summary: 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.

Detailed Description: 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).