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Brief Title: A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
Official Title: 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
Study ID: NCT03295942
Brief 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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Name: Kyriakos P Papadopoulos, MD
Affiliation: South Texas Accelerated Research Therapeutics, LLC
Role: PRINCIPAL_INVESTIGATOR