Phase I/Ib FIH study of EOS100850 in patients with advanced cancers
Research type
Research Study
Full title
Phase I/Ib First-in-Human Study of EOS100850 in Participants with Advanced Cancers
IRAS ID
262958
Contact name
Johann de Bono
Contact email
Sponsor organisation
iTeos Therapeutics SA
Eudract number
2018-003173-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
144547, IND
Duration of Study in the UK
2 years, 9 months, 0 days
Research summary
This is a first-in-human (FIH) clinical study (research study) to evaluate a new drug (medication) called EOS100850 for the treatment of participants with advanced cancers for whom no further standard treatment is available. First-in-human means there has been no prior human experience with the study drug.
The study medication EOS100850 is a medicinal product that is being studied to evaluate how effective and safe the medication is and also its mechanism of action.
The sponsor of the study and the doctor who performs the study (called “investigator”) hope that this study medication may offer advantages in the treatment of participants with advanced cancers.
The study will be conducted in multiple staggered parts, but only 2 of them are being performed in the UK (Parts 1A and 2A).
The first part (Part 1A) is a dose-escalation phase to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as the safety of EOS100850 monotherapy in participants with advanced malignancies. Approximately 45 participants with advanced tumours are expected to be treated in the Part 1A dose-escalation phase of the study.
The second part (Part 2A) of the study is called “expansion phase” to further investigate the study medication at the recommended dose.
For Part 2A phase of the study up to approximately 54 participants will be treated as follows:
• about 13 to 27 participants with advanced urothelial cancer, and
• about 13 to 27 participants with castrate-resistant prostate cancer.This study will take about 2 years 9 months to complete.
The study sponsor is iTeos Belgium SA, Belgium.REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1044
Date of REC Opinion
10 Sep 2019
REC opinion
Further Information Favourable Opinion