EVICTION Study
Research type
Research Study
Full title
A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study)
IRAS ID
282711
Contact name
Johann De Bono
Contact email
Sponsor organisation
ImCheck Therapeutics, Inc.
Eudract number
2019-003847-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
The objective of this clinical trial is to evaluate, for the first time in humans, the safety, tolerability and efficacy of the study drug ICT01 delivered intravenously as a stand-alone therapy and in combination with an already approved medication known as an immune checkpoint inhibitor (ICI), in patients with advanced-stage solid tumours or haematologic cancers who have not responded to other treatments.
The study is composed of two parts:
- 1: dose escalation of ICT01 alone or in combination with an approved anti-cancer drug known as an Immune Checkpoint Inhibitor (ICI)
- 2: expansion stage of ICT01 alone or in combination with an approved ICI
”First-in-human” means that it is the first time that ICT01 is administered to humans, the focus is on understanding the safety profile, rather than proving its efficacy in treating a disease.
”Open-label” means the patient and study doctor will know the treatment received.
“Dose escalation” means that a range of increasing doses of ICT01 will be administered to patients until significant clinical activity or safety and tolerability concerns are identified.
“Immune Checkpoint Inhibitor” is a type of immunotherapy agent that can help inhibit immune checkpoint mechanisms which are often activated and suppress early anti-tumour immune response.
The main aims of this first part of the study are to evaluate how well ICT01 is tolerated by patients by monitoring side effects and to determine the best doses for additional testing. The effects of the product will also be tested as well as its efficacy in treating the disease. The highest safe and active doses will be considered as the recommended dose for the second part in order to achieve the highest possible efficacy in combating malignant tumours with minimal side effects.25 patients will be enrolled at 4 sites in the UK.
197 patients will be enrolled globally across Spain, Germany, France, Belgium and the USA.REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0683
Date of REC Opinion
1 Jun 2020
REC opinion
Favourable Opinion