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

RecruitingPhase 1

A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
* Participants with MF or ET as defined in the protocol.

Exclusion Criteria:

* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
* Participants with laboratory values exceeding the protocol defined thresholds.
* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
* Active invasive malignancy over the previous 2 years.
* History of clinically significant or uncontrolled cardiac disease.
* Active or chronic HBV or active HCV or known history of HIV.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

About the study

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.

What is being tested

Sponsor: Incyte Corporation · Participants: 290 · Started: Dec 4, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06034002

Locations in the U.S.

CaliforniaCity of Hope Medical Center, Duarte
Stanford Cancer Institute, Palo Alto
FloridaUniversity of Miami Health System, Miami
KansasThe University of Kansas Cancer Center, Westwood
MarylandJohns Hopkins Hospital, Baltimore
MassachusettsDana Farber Cancer Institute, Boston
MissouriWashington University School of Medicine, St Louis
New YorkIcahn School of Medicine At Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
North CarolinaWake Forest Baptist Medical Center, Winston-Salem
OhioCleveland Clinic, Cleveland
TennesseeVanderbilt University Medical Center, Nashville
TexasMd Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.