Study of INCA036978 in Participants With Myeloproliferative Neoplasms

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT07441694
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCA036978 — DRUG
    INCA036978 will be administered at protocol defined dose.
  • Standard disease-directed therapy — DRUG
    A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.

Study Details

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.

Key Dates

Start date
May 11, 2026
Status verified
May 2026
Primary completion
May 24, 2030
Completion
May 24, 2030

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities (DLT)s in Part 1 [ Time Frame: Up to 28 days ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
University of Alabama At BirminghamBirminghamAlabama35233-
City of Hope-Lennar Foundation Cancer CenterIrvineCalifornia92618-
UCLA Medical Hematology & OncologyLos AngelesCalifornia90095-
Usc Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Yale Cancer CenterNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
John Hopkins HospitalBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63108-
Mount Sinai School of MedicineNew YorkNew York10029-
Weill Cornell MedicineNew YorkNew York10065-
University of North Carolina At Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical Center, Department of Hematologic Malignancies and Cellular TherapyDurhamNorth Carolina27705-
Cleveland ClinicClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
Tristar Bmt/TctoNashvilleTennessee37203-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham· Birmingham, ALCity of Hope-Lennar Foundation Cancer Center· Irvine, CAUCLA Medical Hematology & Oncology· Los Angeles, CAUsc Norris Comprehensive Cancer Center· Los Angeles, CAYale Cancer Center· New Haven, CTUniversity of Miami· Miami, FL

Related Studies