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

NCT ID: NCT03119428

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2019-05-15

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.

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).

Conditions

Locally Advanced Cancer; Metastatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OMP-313M32

Intravenous (in the vein) infusions of OMP-313M32 as a single agent

Group Type: EXPERIMENTAL

OMP-313M32

Intervention Type: DRUG

OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.

OMP-313M32 and Nivolumab

Intravenous (in the vein) infusions of OMP-313M32 in combination with nivolumab

Group Type: EXPERIMENTAL

OMP-313M32

Intervention Type: DRUG

OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.

Nivolumab

Intervention Type: DRUG

Human IgG4 anti-PD-1 monoclonal antibody

Interventions

OMP-313M32

OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.

Intervention Type: DRUG

Nivolumab

Human IgG4 anti-PD-1 monoclonal antibody

Intervention Type: DRUG

Other Intervention Names

Anti-TIGIT monoclonal antibody; Opdivo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoMed Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Lewicki, PhD

Role: STUDY_DIRECTOR

Mereo BioPharma

Locations

Scottsdale

Scottsdale, Arizona, United States

Durham

Durham, North Carolina, United States

Oklahoma

Oklahoma City, Oklahoma, United States

Nashville

Nashville, Tennessee, United States

Salt Lake City

Salt Lake City, Utah, United States

Countries

United States

References

Mettu NB, Ulahannan SV, Bendell JC, Garrido-Laguna I, Strickler JH, Moore KN, Stagg R, Kapoun AM, Faoro L, Sharma S. A Phase 1a/b Open-Label, Dose-Escalation Study of Etigilimab Alone or in Combination with Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2022 Mar 1;28(5):882-892. doi: 10.1158/1078-0432.CCR-21-2780.

Reference Type: DERIVED

PMID: 34844977 (View on PubMed)

Other Identifiers

313M32-001

Identifier Type: -

Identifier Source: org_study_id