drugset / Trial / NCT05552469

Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases

NCT05552469

Phase 1 Active not recruiting 62 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).

Timeline

Start
2023-05-08
Primary completion
2027-01-13
Completion
2027-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject DFV890 Unknown

Indications