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Locally Advanced CancerPhase 1NCT03119428

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

A Phase 1 study testing OMP-313M32 and Nivolumab in people with Locally Advanced Cancer and Metastatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced Cancer, Metastatic Cancer
What is being tested?
OMP-313M32 and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
5 sitesUnited States
Study dates
2 May 2017to 15 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Durham

    Durham, North Carolina, 27710

  • Nashville

    Nashville, Tennessee, 37203

  • Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Salt Lake City

    Salt Lake City, Utah, 84112

  • Scottsdale

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
OMP-313M32, Nivolumab
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMP-313M32Drug

    Also called Anti-TIGIT monoclonal antibody

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

  • NivolumabDrug

    Also called Opdivo

    Human IgG4 anti-PD-1 monoclonal antibody

Study groups in NCT03119428
Study groupRoleWhat they receive
OMP-313M32ExperimentalIntravenous (in the vein) infusions of OMP-313M32 as a single agent
Receives: Drug: OMP-313M32
OMP-313M32 and NivolumabExperimentalIntravenous (in the vein) infusions of OMP-313M32 in combination with nivolumab
Receives: Drug: OMP-313M32; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Incidence of treatment emergent adverse events

    Percentage of patients with adverse events

    Measured: up to approximately 2 years

Secondary outcomes (7)

  1. Pharmacokinetic Outcome Measures (AUC) - Phase 1a

    Area under the plasma concentration versus time curve (AUC) will be evaluated

    Measured: 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.

  2. Pharmacokinetic Outcome Measures (AUC) - Phase 1b

    Area under the plasma concentration versus time curve (AUC) will be evaluated

    Measured: 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.

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

    The half life (T1/2) of OMP-313M32 will be assessed

    Measured: 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.

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

    The half life (T1/2) of OMP-313M32 will be assessed

    Measured: 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.

  5. Immunogenicity of OMP-313M32

    Percentage of patients with anti-OMP-313M32 antibodies assessed

    Measured: up to approximately 2 years

  6. Objective Response

    Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: up to approximately 2 years

  7. Progression-free survival

    Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Measured: approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start2 May 2017
  3. Primary completion15 May 2019
  4. Study completion15 May 2019

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119428
Sponsor's protocol ID
313M32-001
Status last verified
Aug 2020
First submitted
29 Mar 2017
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34844977

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMP-313M32 and Nivolumab in people with Locally Advanced Cancer and Metastatic Cancer, run by OncoMed Pharmaceuticals, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03119428, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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