Clinical Trials

Date: 2017-05-04

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: OncoMed Pharmaceuticals (USA - CA)

Product: OMP-313M32 (anti-TIGIT)

Action mechanism: monoclonal antibody/immune checkpoint inhibitor. OMP-313M32 is an anti-TIGIT (T-cell immunoreceptor with Ig and ITIM domains) antibody. TIGIT is expressed on many different tumor types. It blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OMP-313M32 is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.

Disease: solid tumors

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: The purpose of this study is to evaluate the safety and efficacy of OMP-31M32. 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. (NCT03119428)

Latest news:

• • On May 4, 2017, OncoMed Pharmaceuticals announced that the first patient has been dosed in the Phase 1a clinical trial of anti-TIGIT (OMP-313M32). The trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors. Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT. Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored. Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels. Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types. The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. This program is part of OncoMed's Celgene collaboration.

Is general: Yes