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

Launched by INCYTE CORPORATION · Jun 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INCA033989, which is being tested either on its own or combined with another drug called ruxolitinib. The goal is to find out how safe this treatment is, how well it is tolerated by patients, and to determine the highest dose that can be given without causing serious side effects. The trial is specifically for people with certain blood disorders known as myeloproliferative neoplasms, which include conditions like myelofibrosis (MF) and essential thrombocythemia (ET).

To participate, individuals should be at least 18 years old and have a life expectancy of more than six months. They must also be willing to have specific tests, including bone marrow biopsies, to monitor their condition. However, those with other serious blood cancers, recent significant health issues like major bleeding or heart problems, or who have received certain treatments recently may not be eligible. Participants can expect regular check-ins and assessments throughout the study to ensure their safety and to monitor how well the treatment is working.

Gender

ALL

Eligibility 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 and ET as defined in the protocol.
• Exclusion Criteria:
• • 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.
• • Other protocol-defined Inclusion/Exclusion Criteria may apply.