A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors
- Conditions
- Locally Advanced Malignant NeoplasmMetastatic Cancer
- Interventions
- Registration Number
- NCT03295942
- Lead Sponsor
- OncoMed Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OMP-336B11 OMP-336B11 Intravenous (in the vein) infusions of OMP-336B11
- Primary Outcome Measures
Name Time Method The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11 Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29) Incidence of dose limiting toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Outcome Measures (CL) Screening through 12 weeks post treatment termination Clearance (CL) will be evaluated
Pharmacokinetic Outcome Measures (Vd) Screening through 12 weeks post treatment termination Volume of distribution (Vd) will be evaluated
Pharmacokinetic Outcome Measures (T1/2) Screening through 12 weeks post treatment termination The half life (T1/2) of OMP-336B11 will be assessed
Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies) up to approximately 2 years Percentage of patients with anti-336B11 antibodies assessed
Progression-Free Survival up to approximately 2 years Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Objective Response up to approximately 2 years Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Trial Locations
- Locations (1)
South Texas Accelerated Research Therapeutics, LLC
🇺🇸San Antonio, Texas, United States