Study of Inupadenant Hydrochloride in Patients with Advanced Cancers
Research type
Research Study
Full title
A Multicenter, Open-Label, Phase I Clinical Study to assess the Safety, Tolerability, Pharmacokinetics and Food-Effect of Inupadenant New Formulation in Participants with Advanced Solid Tumors
IRAS ID
293694
Contact name
Prof. Johann de Bono
Contact email
Sponsor organisation
iTeos Belgium SA
Eudract number
2020-005861-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
In this clinical study we plan to include up to 64 participants with advanced cancer for whom no standard treatment is further available or for participants who have declined standard treatment.
The study will consist of 2 parts (Part 1A - dose escalation and Part 1B - food effect). Up to 40 participants will be included in Part 1A and up 24 participants will be included in Part 1B.
Inupadenant (free base) is being studied in monotherapy and combination in an ongoing study, IO-001. The medication that will be used in this study is a new formulation of inupadenant (inupadenant hydrochloride salt). The new formulation is being developed to better dissolve in the stomach and have better absorption compared to inupadenant. Therefore, while this particular formulation will be the first test in humans in Part 1A, the earlier free base formulation has been previously tested.
Currently the ongoing study shows that inupadenant is well tolerated by patients and it has no safety concerns.
The primary aim of Part 1B of the study is to assess how food consumed with the study medication may affect the level of the drug in the blood.Furthermore, the study will assess what happens to the study medication in the body, how the body gets rid of the study medication, what effects the study medication has on the body, and the effect of the study medication on tumour. The effects of the study medication will be investigated in blood samples, samples of the tumour, and by measuring changes in the size of tumours.
There is no guarantee that participants will directly benefit from taking part in this study. We will enroll participants in 4 study sites in Belgium and the UK.
The study will take about 3 years to complete and is being sponsored by iTeos Belgium SA, Belgium.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0407
Date of REC Opinion
15 Jul 2021
REC opinion
Favourable Opinion