drugset / Trial / NCT05201066

Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.

NCT05201066

Phase 2 Active not recruiting 33 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events.

Timeline

Start
2023-02-13
Primary completion
2028-02-14
Completion
2028-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject ASTX727 Unknown 20 mg/m2 Oral
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Sabatolimab Monoclonal antibody 200 mg Intravenous
Subject Sabatolimab Monoclonal antibody 400 mg Intravenous
Subject Sabatolimab Monoclonal antibody 800 mg Intravenous
Subject Spartalizumab Monoclonal antibody 100 mg Intravenous
Subject Venetoclax Small molecule 400 mg Oral