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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Locally Advanced Malignant Neoplasm, Metastatic Cancer

Intervention / Treatment
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* Drug: OMP-336B11


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: OMP-336B11
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMP-336B11<br>Intravenous (in the vein) infusions of OMP-336B11 | Drug: OMP-336B11<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11 | Incidence of dose limiting toxicities (DLTs) | Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Outcome Measures (CL) | Clearance (CL) will be evaluated | Screening through 12 weeks post treatment termination | 
| Pharmacokinetic Outcome Measures (Vd) | Volume of distribution (Vd) will be evaluated | Screening through 12 weeks post treatment termination | 
| Pharmacokinetic Outcome Measures (T1/2) | The half life (T1/2) of OMP-336B11 will be assessed | Screening through 12 weeks post treatment termination | 
| Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies) | Percentage of patients with anti-336B11 antibodies assessed | up to approximately 2 years | 
| Objective Response | Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to approximately 2 years | 
| Progression-Free Survival | Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | up to approximately 2 years |