Phase 1, Open-Label, Study of INCB160058 in Participants With Myeloproliferative Neoplasms
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms
IRAS ID
1012793
Contact name
Caroline Valentin
Contact email
Sponsor organisation
Incyte Corporation
ISRCTN Number
ISRCTN14695157
Clinicaltrials.gov Identifier
Research summary
This study will recruit people who have been diagnosed with myelofibrosis (MF), polycythemia vera (PV), or essential thrombocythemia (ET) - collectively known as myeloproliferative neoplasms (MPN) - and have a positive JAK2V617F mutation. Myeloproliferative neoplasm (MPNs) are blood cancers in which the bone marrow produces too many blood cells (oxygen-carrying cells [red blood cells], infection-fighting cells [white blood cells], or blood-clotting cells [platelets]). MPNs can be caused by a change (mutation) in the JAK2 gene called JAK2V617F, which causes the bone marrow to make abnormal blood cells. These conditions can lead to problems like anaemia, bleeding, or increased risk of blood clots. INCB160058 is an oral drug (medicine you take by mouth) that is designed to block the mutation and help control the overproduction of blood cells that aren’t working well. This study is being done to find out how INCB160058 works in the body, to find the adequate dose, to find out if there are any side effects (unwanted medical events that the study doctor thinks might be related to INCB160058), and to find out if it works to treat MPNs. This study is also being done to see how INCB160058 works in combination with a standard disease-directed therapy to treat myelofibrosis with the JAK2V617F mutation.
This study is conducted in two parts. Dose escalation tests different doses of the study drug whereas the second part, dose expansion, will further test how safe, tolerable and effective the study drug is. Each participant will be in this study for approximately 12 months.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0862
Date of REC Opinion
20 Jan 2026
REC opinion
Further Information Favourable Opinion