Tests INCA036978 for safety in people with myeloproliferative neoplasms
Tests INCA036978, alone or with standard therapy, in adults with myeloproliferative neoplasms.
Plain-language title generated from the registry record
Registry title: Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Key facts
- Where
- Montreal and Toronto, CanadaSee the 2 sites
- Phase
- Phase 1
Where in Canada
- McGill University - Jewish General HospitalMontreal, CanadaNot yet recruiting
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07441694EU 2026-525217-31-00
- Record updated
- 30 October 2026
- Original description
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.Read full original descriptionShow less
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
Inclusion: Life expectancy > 6 months; Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease); Participants with MF, PV and ET as defined in the protocol.
Exclusion: Malignancy within the last 3 years prior to enrollment; Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months; Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment; Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug; Prior radiation therapy within 28 days before the first dose of study treatment; Other protocol-defined Inclusion/Exclusion Criteria may apply; Presence of any hematological malignancy other than MF, PV, or ET; Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection; Clinically significant or uncontrolled cardiac disease; Presence of chronic or current active infectious disease requiring systemic treatment; Laboratory values outside the Protocol-defined ranges.