INCB086550 in Participants With Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
IRAS ID
282291
Contact name
Rebecca Sophie KRISTELEIT
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2019-004377-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study is designed to assess the clinical activity and safety of INCB086550 in participants with advanced solid tumors.
INCB086550 is an orally administered inhibitor of programmed death ligand-1 (PD-L1) that is being developed for the treatment of advanced cancer. PD-L1 is a protein that helps keep immune cells from attacking non-harmful cells in the body. Some cancer cells hide from the body’s immune system by taking control of PD-L1 pathway, which is a pathway normal healthy cells use to tell the immune system not to attack them. INCB086550 is made to attach to the PD-L1 protein and block this pathway, allowing the immune system to recognize and attack the cancer cells, which is an accepted way to treat many types of cancer.
The study is in 3 parts; in part 1 increasing doses of INCB086550 are evaluated in small groups of patients until the highest dose that is safe and tolerated by most patients is found. Part 2 will determine whether the dose from Part 1 is effective in certain cancer types while collecting further safety data. In Part 3 participants with selected tumors will be evaluated for safety and effectiveness.
Participants will sign an informed consent form and undergo screening procedures. If they meet the inclusion/exclusion criteria, they will be enrolled into the study and receive the study treatment. Participants will make repeated visits to the hospital for tests including blood tests, tissue sampling and scans involving radiation.
Treatment with study drug may continue up to 2 years in the absence of clinical disease progression, unacceptable toxicity, death, withdrawal of consent, lost to follow-up, or premature discontinuation for any other reason. Patients completing treatment or prematurely discontinuing the study will be followed-up until study assessments have been completed.
The study will enroll approximately 130 participants in total.
Lay summary of study results: A summary of final results has been submitted to the EU Clinical Trials Register.
European clinical trial register and Clinicaltrials.govREC name
London - City & East Research Ethics Committee
REC reference
20/LO/1001
Date of REC Opinion
15 Sep 2020
REC opinion
Favourable Opinion