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

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT06034002
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

  • INCA033989 — DRUG
    INCA033989 will be administered at protocol defined dose.
  • Ruxolitinib — DRUG
    Rux will be administered according to Prescribing Information/SmPC.

Study Details

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.

Key Dates

Start date
Dec 4, 2023
Status verified
Apr 2026
Primary completion
Oct 29, 2028
Completion
Oct 29, 2028

Study Design

Enrollment
290 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Stanford Cancer InstitutePalo AltoCalifornia94304-
University of Miami Health SystemMiamiFlorida33136-
The University of Kansas Cancer CenterWestwoodKansas66205-
Johns Hopkins HospitalBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Washington University School of MedicineSt LouisMissouri63108-
Icahn School of Medicine At Mount SinaiNew YorkNew York10029-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44195-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAStanford Cancer Institute· Palo Alto, CAUniversity of Miami Health System· Miami, FLThe University of Kansas Cancer Center· Westwood, KSJohns Hopkins Hospital· Baltimore, MDDana Farber Cancer Institute· Boston, MA

Related Studies