D6450C00001 Phase 1 Study of MEDI5395 with Durvalumab in Solid Tumours

• Research type

  Research Study

• Full title

  An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination with Durvalumab in Subjects with Select Advanced Solid Tumors

• IRAS ID

  263137

• Contact name

  Kevin Harrington

• Contact email

  kevin.harrington@icr.ac.uk

• Sponsor organisation

  MedImmune, LLC

• Eudract number

  2017-000851-16

• Clinicaltrials.gov Identifier

  NCT03889275

• Duration of Study in the UK

  5 years, 4 months, 19 days

• Research summary

  Summary of Research

  Cancer continues to be a major global health burden. Despite considerable advancements made during the last decade, there continues to be an unmet medical need for more effective and less toxic therapies.

  This research is being done to find out if using two medications, MEDI5395 and durvalumab, will work and be safe for the treatment of solid tumours. MEDI5395 and durvalumab are types of cancer immunotherapies, also called biologic therapies, that try to boost the body’s natural immune defences to fight cancer.

  MEDI5395 is an oncolytic virus (a virus that infects and breaks down cancer cells but not normal cells) that has been engineered to also help the body’s defence system recognise and destroy cancer cells. Durvalumab, a targeted therapy that boosts the immune system to attack cancer cells, may fight cancer cells better when given with MEDI5395.

  This is a Phase 1, first time in human, open-label (patients and investigators will know what treatment the participant is receiving) , dose-escalation, and dose-expansion study. Dose escalation means looking at a progressive increase in dose to investigate a maximum tolerated or administered dose of a treatment or combination of treatments. Dose expansion means looking at the tolerability and safety of the drugs. The study will also look at:
  - The overall safety and tolerability of the treatment combination
  - Pharmacokinetics (PK) (what the body does to the drugs)
  - Pharmacodynamics (what the drugs do to the body)
  - Preliminary efficacy (effectiveness) of MEDI5395 in combination with durvalumab
  when given to patients with selected advanced solid tumours

  The study will consist of a 28 day screening period followed by up to a 2 year treatment period.

  Study procedures will include: Blood, urine and saliva samples, ECGs, Echocardiograms (ECHOs), CT/MRI scans and tumour biopsies.

  Up to approximately 164 participants may be enrolled in the study across approximately 30 sites globally.

  Summary of Results

  https://www.trialsummaries.com/Study/StudyDetails?id=11066&tenant=MT_MED_9011

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  19/SC/0405

• Date of REC Opinion

  13 Dec 2019

• REC opinion

  Further Information Favourable Opinion