Study of INCA036978 in Participants With Myeloproliferative Neoplasms

ID#: NCT07441694

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: May 11, 2026

End Date: May 24, 2030

Contact Information:
Incyte Corporation Call Center (US)
1.855.463.3463
Incyte Corporation Call Center (ex-US)
+800 00027423
Summary: 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.
Eligibility:

Inclusion Criteria:

- 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 Criteria:

- Presence of any hematological malignancy other than MF, PV, or ET.

- Malignancy within the last 3 years prior to enrollment.

- Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.

- Clinically significant or uncontrolled cardiac disease.

- Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.

- Laboratory values outside the Protocol-defined ranges.

- Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.

- Presence of chronic or current active infectious disease requiring systemic treatment.

- 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.
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