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A Phase 1, Open-Label, Multicenter Study of INCA033989 in Participants With Myeloproliferative Neoplasms


Description

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 in participants with myeloproliferative neoplasms.

Trial Eligibility

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 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 Info

Organization

Incyte Corporation


Primary Outcome

Number of participants with Dose Limiting Toxicities (DLTs)


Outcome Timeframe Up to 28 days

NCTID NCT06034002

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-12-04

Completion Date 2028-10-29

Enrollment Target 140

Interventions

DRUG INCA033989

Locations Recruiting

City of Hope Medical Center

United States, California, Duarte


Stanford Cancer Institute

United States, California, Palo Alto


University of Miami Health System

United States, Florida, Miami


Moffitt Cancer Center

United States, Florida, Tampa


The University of Kansas Cancer Center

United States, Kansas, Westwood


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