Oncolytic Vaccinia Virus in Patients with Advanced Solid Tumours

• Research type

  Research Study

• Full title

  A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered Alone and in Combination with Pembrolizumab, in Patients with Advanced Solid Tumors

• IRAS ID

  303720

• Contact name

  Kevin Harrington

• Contact email

  Kevin.Harrington@icr.ac.uk

• Sponsor organisation

  Turnstone Biologics, Corp

• Eudract number

  2021-001001-79

• Clinicaltrials.gov Identifier

  NCT04301011

• Duration of Study in the UK

  2 years, 2 months, 7 days

• Research summary

  This trial is for people with advanced solid tumour cancers for which there is no further standard treatment. A solid cancer is any cancer apart from cancers of the blood such as leukaemia and lymphoma.

  The main aims of this trial are to:
  • find out the best dose of TBio-6517 to give by itself and in combination with the pembrolizumab
  • find out how well TBio-6517 and pembrolizumab work as a treatment for advanced solid tumours and to learn more about the side effects

  The investigational drug, TBio-6517 is a Copenhagen Vaccinia Virus that has been genetically attenuated (weakened) to selectively infect and replicate within cancer cells, and not normal, healthy cells. It is injected directly into the tumour or given by infusion (IV). Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. It is approved for use in some cancers but its use with TBio-6517 is considered experimental.

  This trial consists of two parts. In the Phase 1 dose escalation part of the study, the first few people to take part will have a low dose of TBio-6517. If they don’t have any bad side effects the next few will have a higher dose. This continues until the highest safe dose is found. After this they want to find the best dose of TBio-6517 to give with Pembrolizumab, which may or may not be the same as the highest safe dose found in Phase 1. In the Phase 2a dose expansion part of the study more people with certain cancers will be invited to join the study. They will all receive the TBio-6517 + Pembrolizumab combination at the same recommended dose from Phase 1 part of the study.

  Participants will be asked to attend the hospital more frequently than normal and have extra tests that all above normal clinical care. This includes blood tests, scans and new biopsies for tumour tissue. This is the first time TBio-6517 is being used in humans and there may be unexpected side effects that we don’t know about yet. All participants in the UK will require observation for a minimum of 24 hours following each TBio-6517 treatment. Up to 205 people worldwide and 30 people from the UK will be invited to take part in the study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  22/SC/0055

• Date of REC Opinion

  4 May 2022

• REC opinion

  Further Information Favourable Opinion