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

NCT03119428 | Terminated Phase 1 FDA Drug

• 1 other identifier: 313M32-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

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.

Conditions

Locally Advanced Cancer; Metastatic Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLTs)

  The Maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-313M32 in combination with nivolumab

  Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)

• Incidence of treatment emergent adverse events

  Percentage of patients with adverse events

  up to approximately 2 years

Secondary Outcomes (7)

• Pharmacokinetic Outcome Measures (AUC) - Phase 1a

  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.

• Pharmacokinetic Outcome Measures (AUC) - Phase 1b

  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.

• Pharmacokinetic Outcome Measures (T1/2) - Phase 1a

  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.

• Pharmacokinetic Outcome Measures (T1/2) - Phase 1b

  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.

• Immunogenicity of OMP-313M32

  up to approximately 2 years

Study Arms (2)

OMP-313M32

EXPERIMENTAL

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

Drug: OMP-313M32

OMP-313M32 and Nivolumab

EXPERIMENTAL

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

Drug: OMP-313M32; Drug: Nivolumab

Interventions

OMP-313M32 DRUG

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

Also known as: Anti-TIGIT monoclonal antibody

OMP-313M32; OMP-313M32 and Nivolumab

Nivolumab DRUG

Human IgG4 anti-PD-1 monoclonal antibody

Also known as: Opdivo

OMP-313M32 and Nivolumab

Eligibility Criteria

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

You may qualify if:

• 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.
• Ability to understand the willingness and to sign a written informed consent document
• Age \>/= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy \>/=12 weeks
• Measurable disease per response evaluation criteria in solid tumors.
• Adequate hematologic and organ 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.

You may not qualify if:

• 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
• 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.
• Inability to comply with study and follow-up procedures.
• Pregnancy, lactation, or breastfeeding women.
• 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.
• Known clinically significant liver disease,
• 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.
• 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.

Sponsors & Collaborators

• OncoMed Pharmaceuticals, Inc.: lead

Study Sites (5)

Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Durham

Durham, North Carolina, 27710, United States

Location

Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Nashville

Nashville, Tennessee, 37203, United States

Location

Salt Lake City

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 34844977 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Lewicki, PhD

  Mereo BioPharma

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 18, 2017
• Study Start: May 2, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)