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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Cancer; Locally Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: OMP-336B11

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMP-336B11; Intravenous (in the vein) infusions of OMP-336B11	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OncoMed Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Kyriakos P Papadopoulos, MD, South Texas Accelerated Research Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): July 4, 2019
• Study Completion (Actual): July 4, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 336B11-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No