Sponsor decision

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.

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.

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