A study of INCB106385 combined with immunotherapy in solid tumours
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors
IRAS ID
304113
Contact name
Carol Penning
Contact email
Sponsor organisation
Incyte
Eudract number
2020-002921-27
Clinicaltrials.gov Identifier
150314, IND
Duration of Study in the UK
1 years, 9 months, 25 days
Research summary
Summary of Research
This is a study of using an investigational drug called INCB106385 in patients with solid tumours alone (monotherapy) or in combination with another drug called INCMGA00012.
INCB106385 is a small molecule that has been designed to moderate the activity of certain “messenger” molecules involved in the body’s immune response, called adenosine. Adenosine prevents the immune system from targeting and destroying healthy tissue; however, it can also prevent the immune system from targeting and destroying cancer cells.
INCMGA00012 is a monoclonal antibody. When the body’s immune system detects something harmful, it produces antibodies. Antibodies are proteins that fight infection. Monoclonal antibodies are a specific type of antibody made in a laboratory. They can attach to other molecules or cells in your body and affect their function.
Some cancer cells hide from your body’s immune system by taking control of what is called the PD-1 pathway, which is a pathway normal healthy cells use to tell the immune system not to attack them. INCMGA00012 is made to attach to the PD-1 protein and block this pathway, allowing the immune system to recognize and attack the cancer cells, which is an accepted way to treat many cancers.
This study will see if INCB106385 can destroy the cancer cells better by itself or in combination with the INCMGA00012 immunotherapy molecule.
This study will consist of 2 parts, part 1 is the dose-escalation and will determine the recommended dose of INCB106385 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.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0208
Date of REC Opinion
1 Dec 2021
REC opinion
Further Information Favourable Opinion