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Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Study of INCA036978 in Participants With Myeloproliferative Neoplasms

NCT07441694

RecruitingPhase 1

Sponsor: Incyte Corporation

Conditions: Myeloproliferative Neoplasms

Interventions: INCA036978, Standard disease-directed therapy

Countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (54)
  • Birmingham, Alabama, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • New Haven, Connecticut, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Milwaukee, Wisconsin, United States
  • Concord, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Auchenflower, Queensland, Australia
  • East Melbourne, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Liège, Belgium
  • Roeselare, Belgium
  • + 24 more on CT.gov