Myeloproliferative neoplasms (MPN)

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

Incyte Study ID:
INCA33989-102
CT.gov ID:
NCT06034002
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myeloproliferative neoplasms (MPN)
    • PRODUCT
  • Drug: INCA033989
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    Dec 2023 - Oct 2028
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    CITY OF HOPE MEDICAL CENTER
    DUARTE, CA, US, 91010
    Status
    Recruiting
    Name
    WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
    SAINT LOUIS, MO, US, 63108
    Status
    Recruiting
    Name
    MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Status
    Recruiting
    Name
    ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
    NEW YORK, NY, US, 10029
    Status
    Recruiting
    Name
    CLEVELAND CLINIC
    CLEVELAND, OH, US, 44195
    Status
    Recruiting
    Name
    DANA FARBER CANCER INSTITUTE
    BOSTON, MA, US, 02215
    Status
    Recruiting
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria:
    • Life expectancy > 6 months.

    Exclusion Criteria

    Requirements information
    Inclusion 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 HBV/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.

    Protocol Summary

    Incyte Study ID:
    INCA33989-102
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCA033989
  • Drug: Ruxolitinib
    • Enrollment:
    230
    Primary Outcome
    Open

    Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 3 years and 60 days

    Secondary Outcome
    Open

    Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF

    Timeframe: Up to 3 years and 60 days

    Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol

    Timeframe: Up to 24 weeks

    Participants with symptomatic anemia: Anemia Response as defined in the protocol

    Timeframe: Up to 24 weeks

    Participants with ET: Response using the revised IWG-MRT and ELN response criteria for ET

    Timeframe: Up to 3 years and 60 days

    Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation

    Timeframe: Up to 3 years and 60 days

    Percentage of participants achieving ≥ 50% reduction from baseline in total symptom score (TSS)

    Timeframe: Week 12 and Week 24

    Mean change from baseline in TSS

    Timeframe: Week 12 and Week 24

    Mean change in disease-related allele burden

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Cmax of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Tmax of INCA033989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Cmin of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: AUC(0-t) of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: AUC 0-∞ of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: CL/F of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Vz/F of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: t1/2 of INCA33989 alone or for the combination of INCA033989 with ruxolitinib

    Timeframe: Up to 3 years and 60 days