drugset / Trial / NCT04283526

Study of Select Combinations in Adults With Myelofibrosis

NCT04283526

Phase 1 Withdrawn Novartis Pharmaceuticals
Non-randomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to investigate the safety, pharmacokinetics (PK) and preliminary efficacy of both the combination of MBG453 and NIS793 with or without decitabine or spartalizumab as well as single agent MBG453 and/or NIS793 single agent in myelofibrosis (MF) subjects post treatment with a Janus Kinase (JAK) inhibitor. In this study, combination therapies with novel agents including immune therapy will focus on determining the promising combinations that provide acceptable safety and efficacy independent of JAK inhibitors. Immune therapy combinations, such as MBG453 in combination with NIS793, might offer the potential to target MF across genetic heterogeneity. The primary objective of this study is to characterize the safety, tolerability and recomended dose for each treatment combination (MBG453 + NIS793, MBG453 + NIS793 + decitabine, and MBG453 + NIS793 + spartalizumab)

Timeline

Start
2020-11-30
Primary completion
2024-04-11
Completion
2024-04-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 5 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject NISEVOKITUG Monoclonal antibody 2100 mg Intravenous
Subject Sabatolimab Monoclonal antibody 600 mg Intravenous
Subject Spartalizumab Monoclonal antibody 300 mg Intravenous