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A Study of OMP-313M32 in Subjects With Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03119428
Recruitment Status : Active, not recruiting
First Posted : April 18, 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 evaluate the safety and tolerability of OMP-31M32 as a single agent or in combination with nivolumab. OMP-313M32 is an experimental anti-TIGIT antibody that was developed to block TIGIT from binding PVR allowing the body's T-cells to destroy cancer cells.

Condition or disease Intervention/treatment Phase
Locally Advanced Cancer Metastatic Cancer Drug: OMP-313M32 Drug: Nivolumab Phase 1

Detailed Description:
This is an open-label, Phase 1a/b dose escalation study of OMP-31M32 administered as a single agent or in combination with nivolumab to evaluate the safety, tolerability pharmacokinetics, and pharmacodynamics in patients with locally advanced or metastatic solid 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 2 years. Subjects will be enrolled in two stages in the Phase 1a (dose escalation and expansion) and one stage in the Phase 1b (dose escalation).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of OMP-313M32 Administered as a Single Agent or in Combination With Nivolumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: OMP-313M32
Intravenous (in the vein) infusions of OMP-313M32 as a single agent
Drug: OMP-313M32
OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.
Other Name: Anti-TIGIT monoclonal antibody

Experimental: OMP-313M32 and Nivolumab
Intravenous (in the vein) infusions of OMP-313M32 in combination with nivolumab
Drug: OMP-313M32
OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.
Other Name: Anti-TIGIT monoclonal antibody

Drug: Nivolumab
Human IgG4 anti-PD-1 monoclonal antibody
Other Name: Opdivo




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29) ]
    The Maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-313M32 in combination with nivolumab

  2. Incidence of treatment emergent adverse events [ Time Frame: up to approximately 2 years ]
    Percentage of patients with adverse events


Secondary Outcome Measures :
  1. Pharmacokinetic Outcome Measures (AUC) - Phase 1a [ Time Frame: 1st dose and 4th dose: pre-dose, post-infusion, and 1, 3, 7 and 10 days. All other doses: pre-dose, 15 minutes and 7 days post-infusion. PK sample will be taken at treatment termination and every 4 wks for 12 wks. ]
    Area under the plasma concentration versus time curve (AUC) will be evaluated

  2. Pharmacokinetic Outcome Measures (AUC) - Phase 1b [ Time Frame: 1st dose and 4th dose: pre-dose and 15 minutes post-infusion. All other doses: pre-dose. PK sample will be taken at treatment termination and every 4 wks for 12 wks. ]
    Area under the plasma concentration versus time curve (AUC) will be evaluated

  3. Pharmacokinetic Outcome Measures (T1/2) - Phase 1a [ Time Frame: 1st dose and 4th dose: pre-dose, post-infusion, and 1, 3, 7 and 10 days. All other doses: pre-dose, 15 minutes and 7 days post-infusion. PK sample will be taken at treatment termination and every 4 wks for 12 wks. ]
    The half life (T1/2) of OMP-313M32 will be assessed

  4. Pharmacokinetic Outcome Measures (T1/2) - Phase 1b [ Time Frame: 1st dose and 4th dose: pre-dose and 15 minutes post-infusion. All other doses, pre-dose.PK sample will be taken at treatment termination and every 4 wks for 12 wks. ]
    The half life (T1/2) of OMP-313M32 will be assessed

  5. Immunogenicity of OMP-313M32 [ Time Frame: up to approximately 2 years ]
    Percentage of patients with anti-OMP-313M32 antibodies assessed

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

  7. Progression-free survival [ Time Frame: approximately 2 years ]
    Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic documentation of locally advanced, recurrent or metastatic solid malignancy that has progressed and standard therapy has been ineffective or intolerable. Phase 1b subjects must also have experienced disease progression after treatment with an anti PD-1 or PDL-1 agent.
  2. Ability to understand the willingness and to sign a written informed consent document
  3. Age >/= 18 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. Life expectancy >/=12 weeks
  6. Measurable disease per response evaluation criteria in solid tumors.
  7. Adequate hematologic and organ function
  8. 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.

Exclusion Criteria:

  1. Anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks or 5 half lives, whichever is shorter, prior to initiation of study treatment
  2. Active autoimmune disease or a history of severe autoimmune disease or syndrome
  3. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
  4. Inability to comply with study and follow-up procedures.
  5. Pregnancy, lactation, or breastfeeding women.
  6. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.
  7. Known clinically significant liver disease,
  8. Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study.
  9. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.

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): NCT03119428


Locations
United States, Arizona
Scottsdale
Scottsdale, Arizona, United States, 85258
United States, North Carolina
Durham
Durham, North Carolina, United States, 27710
United States, Oklahoma
Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Nashville
Nashville, Tennessee, United States, 37203
United States, Utah
Salt Lake City
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03119428     History of Changes
Other Study ID Numbers: 313M32-001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: June 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:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents