NCT03295942

A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Malignant Neoplasm
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2017-09-12
• Primary completion: 2019-07-04
• Completion: 2019-07-04
• First posted: 2017-09-28
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study