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

Launched by INCYTE CORPORATION · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called INCA033989 for patients with myeloproliferative neoplasms, which are diseases where the bone marrow makes too many blood cells. The main goals of the trial are to check how safe the treatment is, what the right dose should be, and if any side effects occur at higher doses. The study is currently looking for participants who are between 65 and 74 years old and have a life expectancy of more than six months. To qualify, they need to have specific genetic mutations and be willing to undergo certain medical tests during the trial.

Participants in this study can expect to receive the experimental treatment and will be monitored closely for its effects. They may need to have bone marrow tests done before starting the treatment and regularly throughout the study to assess their condition. It's important to note that certain health conditions and treatments in the past may disqualify someone from participating, such as recent major bleeding, certain cancers, or previous treatments for their disease. Overall, this trial aims to explore a potential new option for managing myeloproliferative neoplasms.

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 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.