IXACT (Ixovex-1 single Agent and Combination Therapy)
Research type
Research Study
Full title
A Phase I/II open-label, clinical trial of intratumoural Ixovex-1 as single agent therapy or in combination with Pembrolizumab in palpable solid tumours
IRAS ID
1008853
Contact name
Imad Mardini
Contact email
Sponsor organisation
Psivac Ltd.
Clinicaltrials.gov Identifier
Research summary
Many solid tumour cancers have shown resistance to traditional approved treatments, including chemotherapy and radiotherapy. The investigational study drug, Ixovex-1 is a type of drug called oncolytic virotherapy. Oncolytic (cancer destroying) viruses are being developed as a potential alternative therapy for the treatment of cancer without some of the side effects seen in traditional treatments. Ixovex-1, has shown promise as an effective therapy in laboratory studies. This is the first time this study drug is being given to humans.
The purpose of this study is to find out if the study drug is safe and effective in targeting and destroying cancer cells without damaging healthy cells in people who have locally advanced (growing, but not spread to other parts of the body), unresectable (cannot be surgically removed), or metastatic tumours (cancer which has spread to other parts of the body).
This study is being done in 3 phases (Ia, Ib, II). There will be from 6 up to 18 participants enrolled in each part of the study.
In Phase Ia, subjects will receive between 2 to 10 mLs of Ixovex-1 approximately every 2 weeks over a period of 8 weeks (4 treatments).
In Phase Ib, subjects will receive combination therapy with Ixovex-1 (the best dose of study drug as determined in Part Ia) and Pembrolizumab at the standard dose. Subjects will receive a total of 4 doses of Ixovex-1 and 8 doses of Pembrolizumab.
In Phase II, subjects will receive combination therapy with Ixovex-1 (the best dose of study drug as determined in Part Ib) and Pembrolizumab at the standard dose. Subjects will receive a total of 4 doses of Ixovex-1 and 8 doses of Pembrolizumab.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0045
Date of REC Opinion
23 Apr 2024
REC opinion
Further Information Favourable Opinion