Status:
TERMINATED
A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
Lead Sponsor:
OncoMed Pharmaceuticals, Inc.
Conditions:
Locally Advanced Malignant Neoplasm
Metastatic Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03295942
Start Date
September 12 2017
End Date
July 4 2019
Last Update
August 11 2020
Active Locations (1)
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1
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229