drugset / Trial / NCT06523556

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

NCT06523556

Phase 1/2 Recruiting 52 enrolled Uma Borate Incyte Corporation · collab
Non-randomizedCrossoverOpen-labelTreatment

Summary

This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN/MDS overlap or high risk CMML.

Timeline

Start
2024-08-02
Primary completion
2027-10-31
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Axatilimab Monoclonal antibody Intravenous
Subject Azacitidine Other / unclassified Intravenous