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



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:4/6/2019
Start Date:September 12, 2017
End Date:July 30, 2019

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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

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
We found this trial at
1
site
San Antonio, Texas 78229
Principal Investigator: Kyriakos P Papadopoulos, MD
Phone: 210-593-5265
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mi
from
San Antonio, TX
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