Recruiting
Phase 1

INCA036978

Sponsor:

Incyte Corporation

Code:

NCT07441694

Conditions

Myeloproliferative Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA036978

Standard disease-directed therapy

Study Details

Brief 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.

Conditions

Myeloproliferative Neoplasms

Study ID

NCT07441694

Start date

May 11, 2026

Status verified date

Jul, 2026

Completion date

May 24, 2030

Anticipated

Primary completion date

May 24, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a: Dose Escalation

INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).

experimental: Part 1b: Dose Escalation

INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).

experimental: Part 2a: Dose Expansion

INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1

experimental: Part 2b: Dose Expansion

INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.

Interventions

INCA036978

INCA036978 will be administered at protocol defined dose.

Standard disease-directed therapy

A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Primary outcome measure

  • Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 [ Time Frame: Up to 28 days ]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]
  • Number of participants with TEAEs leading to dose modification or discontinuation [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Tristar Bmt/Tcto

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Incyte Corporation

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Myeloproliferative Neoplasms
  • Myelofibrosis
  • Essential thrombocythemia
  • Polycythemia Vera

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-07-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.