Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06034002

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Led by Incyte Corporation · Updated on 2026-04-17

290

Participants Needed

13

Research Sites

255 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.

CONDITIONS

Official Title

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Life expectancy greater than 6 months
  • Willingness to undergo pretreatment and regular bone marrow biopsies and aspirates as appropriate
  • Documentation from a qualified laboratory of CALR exon-9 mutation
  • Diagnosis of myelofibrosis or essential thrombocythemia as defined in the protocol
Not Eligible

You will not qualify if you...

  • Presence of any blood cancer other than essential thrombocythemia, primary myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Major bleeding or thrombosis within 3 months before study enrollment
  • Laboratory values exceeding protocol-defined thresholds
  • Prior or planned allogenic or autologous stem-cell transplantation
  • Active invasive cancer within the past 2 years
  • History of significant or uncontrolled heart disease
  • Active or chronic hepatitis B, active hepatitis C, or known HIV infection
  • Prior chemotherapy, immunomodulatory, immunosuppressive, biological, endocrine, targeted therapy, antibody, or hypomethylating agent within 5 half-lives or 28 days before first dose, except ruxolitinib for certain groups
  • Treatment with G-CSF, GM-CSF, or TPO-R agonists within 4 weeks before first dose
  • Other protocol-defined inclusion or exclusion criteria may apply

AI-Screening

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Trial Site Locations

Total: 13 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

Stanford Cancer Institute

Palo Alto, California, United States, 94304

Actively Recruiting

3

University of Miami Health System

Miami, Florida, United States, 33136

Actively Recruiting

4

The University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

5

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

6

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

Washington University School of Medicine

St Louis, Missouri, United States, 63108

Actively Recruiting

8

Icahn School of Medicine At Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

9

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

10

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

11

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

12

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

13

Md Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

I

Incyte Corporation Call Center (US)

CONTACT

I

Incyte Corporation Call Center (ex-US)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

7

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