NCT03119428

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Locally Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	OMP-313M32	OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.
DRUG	Nivolumab	Human IgG4 anti-PD-1 monoclonal antibody

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2017-04-18
• Last updated: 2020-08-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study