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

• Status: Terminated
• Trial end date: 2019-07-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoMed Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Locally advanced or metastatic solid tumors that have exhausted standard of care therapy

• Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1

• Age >21 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ and marrow function

• For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Receiving any other investigational agents or any other anti-cancer therapy

• Active autoimmune disease or a history of severe autoimmune disease or syndrome

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

• Pregnancy, lactating or breastfeeding women

• History of primary CNS malignancy, or leptomeningeal disease or CNS metastases

• Significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study

• Inability to comply with study and follow up procedures