CUBIC
Research type
Research Study
Full title
CUBIC: A phase I/II study of the CXCR2 inhibitor, AZD5069, in combination with Durvalumab (MEDI4736), in patients with advanced Hepatocellular Carcinoma (HCC)
IRAS ID
287628
Contact name
Jeff Evans
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Eudract number
2020-003346-36
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Liver cancer is increasingly common and there are currently few drug therapies of proven effectiveness in patients with advanced disease. Drugs that target a molecule known as PDL-1, such as durvalumab, can enable the immune system to eradicate cancer cells and have some activity in shrinking liver cancer, but not sufficiently to improve survival in patients with advanced disease.
Laboratory experiments suggest that targeting immune cells known as chemokines with a drug called AZD5069 can increase the effects of anti-PDL-1 antibody therapy on liver cancer. In this study, we will find out the recommended dose of AZD5069 when given in combination with durvalumab in patients with liver cancer and determine if this regimen is effective in shrinking liver cancers.
Participants will take AZD5069 tablets twice a day continuously and will receive a drip of durvalumab once every 4 weeks. Treatment will continue for as long as participants are benefiting from and tolerating the treatment. Frequent blood samples will be taken to confirm that this regimen is safe and CT scans will be performed every 8 weeks to look at the effect of treatment on the cancer. A biopsy of the liver tumour will also be performed before starting treatment and once during the first 4-week treatment course.
The potential benefits to participants is that this regimen may be effective in reducing the size of the tumours and improving for how long the cancer can be controlled, and improve patient survival. The main risks are the potential side-effects of the treatment which include low white blood cell count (and infections) and the side-effects of durvalumab which can cause inflammation of various body organs including skin rash, inflammatory bowel effects, liver
inflammation, and deficiency of certain hormones. These side effects usually resolve with steroid treatment.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0023
Date of REC Opinion
1 Feb 2021
REC opinion
Favourable Opinion