Locally Advanced Malignant Neoplasm, Metastatic Cancer
Conditions
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.
Interventions
DRUGOMP-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.
Sponsors
OncoMed Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
OMP-336B11
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | up to approximately 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
| Pharmacokinetic Outcome Measures (CL) | Screening through 12 weeks post treatment termination | Clearance (CL) will be evaluated |
| Objective Response | up to approximately 2 years | Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
| 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 |
| Pharmacokinetic Outcome Measures (Vd) | Screening through 12 weeks post treatment termination | Volume of distribution (Vd) will be evaluated |
Countries
United States
Outcome results
None listed