IOA-244 alone and in combination with pemetrexed/cisplatin
Research type
Research Study
Full title
First-in-Human Dose Study of IOA-244 alone and in combination with pemetrexed/cisplatin in patients with advanced or metastatic cancers
IRAS ID
263483
Contact name
Jeff Evans
Contact email
Sponsor organisation
iOnctura SA
Eudract number
2019-000686-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 0 days
Research summary
In this clinical study, IOA-244 will be given to humans for the first time. This is an open-label and dose-escalation study, meaning that both the participant and the study doctor will know which treatment participants will be receiving in this study (i.e. IOA-244) and that different doses of IOA-244 will be investigated in order to define the optimal effective dose.
This study is designed to collect information on the safety, tolerability, and anti tumor activity of an experimental drug called IOA-244 (study drug). The study will also examine how the drug is changed by and removed from the body and look for indicators that the drug may be effective against cancer.
IOA-244 is a PI3Kδ inhibitor which is a novel drug candidate. PI3Kδ inhibitors have the potential to enhance the immune system’s response to cancer and inhibit tumour growth. Several PI3Kδ inhibitors are either approved or in the process of being approved in blood cancers, however their role in solid tumours has not been well investigated. The purpose of the study is to asses if IOA-244 can be safely administered to patients and may provide additional benefits for the treatment of melanoma and mesothelioma.
Up to 78 patients with melanoma or mesothelioma will be selected to participate in the study. Part A will include up to 24 patients and will be conducted in 2 hospital clinics in the UK and Italy; Part B may include up to 54 patients at additional sites.
Participants will receive up to 6 cycles and be in the study for up to 12 months. Study medication (capsules) will be given at the study clinic on Day 1 of each cycle and patients will take the medication home to continue treatment.
REC name
West of Scotland REC 1
REC reference
19/WS/0086
Date of REC Opinion
15 Jul 2019
REC opinion
Further Information Favourable Opinion