Recruiting
Phase 1

INCA033989

Sponsor:

Incyte Corporation

Code:

NCT06034002

Conditions

Myeloproliferative Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA033989

Ruxolitinib

Study Details

Brief summary:

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

Myeloproliferative Neoplasms

Study ID

NCT06034002

Start date

Dec 4, 2023

Status verified date

Apr, 2026

Completion date

Oct 29, 2028

Anticipated

Primary completion date

Oct 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

290 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1a Dose Escalation Cohort Disease Group A - with MF

INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.

experimental: Part 1a Dose Escalation Cohort Disease Group A - with ET

INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with essential thrombocythemia (ET) will enroll in this group.

experimental: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R

INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.

experimental: Part 1b: Dose Expansion - with MF

INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.

experimental: Part 1b: Dose Expansion - with TGB-MF SubOpt R

INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.

experimental: Part 1b: Dose Expansion - with ET

INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.

experimental: Part 1c: Dose Expansion

INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.

Interventions

INCA033989

INCA033989 will be administered at protocol defined dose.

Ruxolitinib

Rux will be administered according to Prescribing Information/SmPC.

Primary outcome measure

  • Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 years and 60 days ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

University of Miami Health System

Recruiting

Miami, Florida, United States, 33136

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

Icahn School of Medicine At Mount Sinai

Recruiting

New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Incyte Corporation

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Myeloproliferative Neoplasms
  • Myelofibrosis
  • Essential thrombocythemia
  • CALR mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-04-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.