Safety and efficacy of KY1044 and atezolizumab in advanced cancer
Research type
Research Study
Full title
A Phase 1/2, open-label, multi-center study of the safety and efficacy of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies
IRAS ID
254047
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
Pharm Research Associates (UK) Limited
Eudract number
2018-003172-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
139,250, IND Number
Duration of Study in the UK
4 years, 1 months, 0 days
Research summary
This is a phase 1/2, first-in-human, open-label study, investigating the safety and efficacy of immune system regulator KY1044. KY1044 functions as an anti-cancer agent by enhancing the body’s own immune system to become more efficient at killing the cancer cells.
Cancer cells in a tumour can create an immune suppressive micro-environment around themselves, evading detection and destruction by the immune system. This ability is thought to be a major cause of cancer immunotherapy treatment failure, such as with atezolizumab. One immune suppressive mechanism is the expression of ICOS on certain immune cells. KY1044 is able to bind to ICOS, therefore decreasing the immune suppressive microenvironment, thereby enhancing tumour destruction and potentially improving the function of immune therapies, like atezolizumab.
This study has two Phases. Phase 1 will include dose escalation with KY1044 alone and in combination with atezolizumab (36 participants in each group). Phase 2 will continue if anti-tumour activity is seen in Phase 1, using the safe and effective dose identified in Phase 1., =Further evaluating the safety and efficacy of KY1044 alone and/or in combination with atezolizumab in larger cohorts. Participants will undergo a 28-day screening- period. Each treatment cycle will last 21 days. Participants will undergo routine assessments during the study including physical examinations, blood testing, urinalysis and tumour imaging. Treatment will continue until unacceptable toxicity, disease progression or for a maximum of 24 months. A safety follow-up will be performed 90 days after the end of treatment, and participants will be followed up for survival until 24 months after the commencement of treatment with provisions made to continue treatment if clinical benefit is shown. KY1044 and atezolizumab are given by injection (i.v) every three weeks. After the first infusion participants will be monitored for 24hrsor as per institutional standard, subsequent infusions require post-injection 3 hour monitoring.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0775
Date of REC Opinion
17 Dec 2018
REC opinion
Favourable Opinion