* INCB099318 in Participants With Select Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
IRAS ID
293068
Contact name
Carol Penning
Contact email
Eudract number
2019-004990-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 23 days
Research summary
Research summary
This Phase 1, open-label, dose-finding study is intended to investigate the safety and tolerability, pharmacokinetics (how the body interacts with the administered drug), pharmacodynamics (the effects of the drug on the body), and early clinical activity of INCB099318 in select cancers. INCB099318 is an oral, small-molecule that targets programed death ligand-1 PD-L1. PD-L1 is a receptor on the surface of immune cells that plays a critical role in the suppression of an immune response in diseases like cancer and viral infection. The main goal of the study is to establish the active dose and investigate the efficacy in patients with select solid tumors. This study will consist of 2 parts, part 1 is the dose-escalation and will determine the recommended dose(s) of INCB099318 to take forward into Part 2 dose expansion. Part 2 is the dose expansion, where participants will be enrolled at the recommended active dose to further explore safety, effectiveness and pharmacokinetics.
Lay summary of study results
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors was carried out and funded by the sponsor Incyte Corporation. The results have been published on the EU clinical trial register.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0197
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion