A Phase 1b/2 Study with MPH313 in patients with Solid Tumours ACTIVATE

• Research type

  Research Study

• Full title

  A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination with Nivolumab to Subjects with Locally Advanced or Metastatic Solid Tumors

• IRAS ID

  295954

• Contact name

  Angela George

• Contact email

  angela.george@icr.ac.uk

• Sponsor organisation

  Mereo BioPharma 5, Inc.

• Eudract number

  2020-004222-37

• Duration of Study in the UK

  1 years, 11 months, 13 days

• Research summary

  The immune system sends types of cells called T-cells throughout the body to detect and fight infections and diseases including cancers. One way the immune system controls activity of T-cells is through a cellular pathway called the TIGIT. TIGIT is a protein normally found on T-cells alongside another protein called CD226. CD226 can attach to a protein on tumours and tumour-infiltrating immune cells called poliovirus receptor (PVR), allowing the T-cell to attack the tumour. TIGIT, however, can inhibit CD226 and preferentially attach to PVR instead. In this way TIGIT can prevent T-cells from attacking cancer. Mereo has created an antibody called etigilimab. Etigilimab is an investigational study drug that could block TIGIT (anti-TIGIT) from attaching to PVR. This may allow the T-cells to destroy cancer cells. Etigilimab is given every 2 weeks (14 days) by intravenous (by inserting a syringe into a vein) infusion in combination with nivolumab infusion until protocol-defined discontinuation criteria are met. The study will have 3 phases:
  1. A Screening Phase lasting up to 28 days, including Day -28 to Day -1
  2. A treatment period, made up of cycles, each cycle lasting 14 days
  3. A 4 week post treatment termination visit

  The purpose of this study is to determine preliminary clinical activity of the combination of Etigilimab and Nivolumab in several selected tumor groups and identify which subject characteristics, based on histology, biomarker or prior therapy are most like to benefit from this combination.
  

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  21/NE/0148

• Date of REC Opinion

  14 Sep 2021

• REC opinion

  Further Information Favourable Opinion