RecruitingInterventionalPhase 1

A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT ID: NCT07441694Sponsor: Incyte CorporationLast updated: 2026-05-29

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.

Arms & interventions

DrugINCA036978
INCA036978 will be administered at protocol defined dose.
DrugStandard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Outcome measures

Primary

Number of participants with Dose Limiting Toxicities (DLT)s in Part 1
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Time frame: Up to approximately 2 years
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
Time frame: Up to approximately 2 years

Secondary

Pharmacokinetics Parameter: Cmax of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Tmax of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmax,ss of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmin,ss of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC(0-t) of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC 0-∞ of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: CL/F of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Vz/F of INCA036978
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: t1/2 of INCA036978
Time frame: Up to approximately 2 years
For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol
Time frame: Week 12 and Week 24
For participants with MF and anemia: Anemia Response as defined in the protocol
Time frame: Up to approximately 2 years
For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years
For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (22)

University of Alabama At Birmingham

Birmingham, Alabama, 35233

Not Yet Recruiting

City of Hope-Lennar Foundation Cancer Center

Irvine, California, 92618

Not Yet Recruiting

Usc Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Not Yet Recruiting

UCLA Medical Hematology & Oncology

Los Angeles, California, 90095

Not Yet Recruiting

Yale Cancer Center

New Haven, Connecticut, 06510

Not Yet Recruiting

University of Miami

Miami, Florida, 33136

Not Yet Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Not Yet Recruiting

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Not Yet Recruiting

John Hopkins Hospital

Baltimore, Maryland, 21287

Not Yet Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Not Yet Recruiting

Washington University School of Medicine

St Louis, Missouri, 63108

Not Yet Recruiting

Mount Sinai School of Medicine

New York, New York, 10029

Not Yet Recruiting

Weill Cornell Medicine

New York, New York, 10065

Not Yet Recruiting

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514

Not Yet Recruiting

Levine Cancer Institute

Charlotte, North Carolina, 28204

Not Yet Recruiting

Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy

Durham, North Carolina, 27705

Not Yet Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Not Yet Recruiting

Ohio State University

Columbus, Ohio, 43210

Not Yet Recruiting

Tristar Bmt/Tcto

Nashville, Tennessee, 37203

Not Yet Recruiting

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

Not Yet Recruiting

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Not Yet Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Not Yet Recruiting