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

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ClinicalTrials.gov Identifier: NCT03295942
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Metastatic Cancer Drug: OMP-336B11 Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: OMP-336B11
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

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.




Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11 [ Time Frame: 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 :
  1. Pharmacokinetic Outcome Measures (CL) [ Time Frame: Screening through 12 weeks post treatment termination ]
    Clearance (CL) will be evaluated

  2. Pharmacokinetic Outcome Measures (Vd) [ Time Frame: Screening through 12 weeks post treatment termination ]
    Volume of distribution (Vd) will be evaluated

  3. Pharmacokinetic Outcome Measures (T1/2) [ Time Frame: Screening through 12 weeks post treatment termination ]
    The half life (T1/2) of OMP-336B11 will be assessed

  4. Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies) [ Time Frame: up to approximately 2 years ]
    Percentage of patients with anti-336B11 antibodies assessed

  5. Objective Response [ Time Frame: up to approximately 2 years ]
    Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

  6. Progression-Free Survival [ Time Frame: up to approximately 2 years ]
    Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295942


Contacts
Contact: Bob Stagg, PharmD 925-323-9548 Robert.Stagg@oncomed.com
Contact: Leonardo Faoro, MD 650-605-3632 Leondardo.Faoro@oncomed.com

Locations
United States, Texas
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN, MSN    210-593-5265      
Principal Investigator: Kyriakos P Papadopoulos, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
Investigators
Principal Investigator: Kyriakos P Papadopoulos, MD South Texas Accelerated Research Therapeutics, LLC

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03295942     History of Changes
Other Study ID Numbers: 336B11-001
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes