A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Incyte Corporation
225 participants
Sep 25, 2023
INTERVENTIONAL
Conditions
Summary
This study is being conducted to evaluate the safety, tolerability, and 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.
Eligibility
Inclusion Criteria4
- 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 and ET as defined in the protocol.
Exclusion Criteria10
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
- Active invasive malignancy over the previous 2 years.
- Active HBV/HCV, HIV.
- History of clinically significant or uncontrolled cardiac disease.
- Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
- Laboratory values outside the Protocol-defined ranges.
- 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.
- Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
- 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 within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
- For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.
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Interventions
INCA033989 will be administered at protocol defined dose.
Rux will be administered according to Prescribing Information/SmPC.
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT05936359