GSK announces start of phase I oncology study with its ICOS agonist antibody

  • GSK3359609 is the first investigational ICOS agonist antibody to enter human clinical trials

Issued: London

GSK today announced the start of a phase I clinical trial with GSK3359609, an investigational inducibile T-cell costimulator (ICOS) agonist antibody. ICOS is a co-stimulatory receptor that enhances T-cell responses and results in an increased anti-tumour response from the immune system.

The study is a two-part clinical trial to evaluate the safety and pharmacokinetic / pharmacodynamic properties of GSK3359609 in patients with advanced/recurrent solid tumours. The study further aims to identify a dose suitable for development -- as monotherapy in Part 1 and in combination with pembrolizumab (Keytruda®), MSD’s anti-PD-1 therapy, in Part 2. Anti-tumour activity will be evaluated as a secondary endpoint in the study.

Axel Hoos, Senior Vice President and Therapeutic Area Head of Oncology said: “We are at a very exciting point in the development of new immuno-oncology agents which have the potential to expand the results seen with checkpoint inhibitors. Novel targets like ICOS will be at the forefront of these new agents and this study will give us the first look at the effects of stimulating the immune system by activating the ICOS receptor.”

GSK3359609 is an investigational product and is not approved for use anywhere in the world. It is the third of four immuno-oncology assets profiled to investors at GSK’s R&D event in November 2015 to enter the clinic. The company’s Oncology portfolio is one of six core areas of scientific research and development, alongside immuno-inflammation, vaccines and infectious, respiratory and rare diseases.

More information on the clinical trial can be found by searching for NCT02723955 on

This study is being conducted pursuant to an agreement between GSK and Merck Sharp & Dohme Corp. (MSD), through a subsidiary.

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