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

NCT03295942 | Terminated Phase 1 FDA Drug

• 1 other identifier: 336B11-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Malignant Neoplasm; Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetic Outcome Measures (CL)

  Screening through 12 weeks post treatment termination

• Pharmacokinetic Outcome Measures (Vd)

  Screening through 12 weeks post treatment termination

• Pharmacokinetic Outcome Measures (T1/2)

  Screening through 12 weeks post treatment termination

• Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)

  up to approximately 2 years

• Objective Response

  up to approximately 2 years

Study Arms (1)

OMP-336B11

EXPERIMENTAL

Intravenous (in the vein) infusions of OMP-336B11

Drug: OMP-336B11

Interventions

OMP-336B11 DRUG

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.

OMP-336B11

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyriakos P Papadopoulos, MD

  South Texas Accelerated Research Therapeutics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: OMP-336B11

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 28, 2017
• Study Start: September 12, 2017
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)