drugset / Trial / NCT04937166
A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies
NaSequentialOpen-labelTreatment
Summary
This study will be divided into two parts, Parts A and B and will enroll patients with relapsed/refractory AML or MDS/chronic myelomonocytic leukemia (CMML) patients who have failed up to 2 prior therapeutic regimens. Part A is a dose escalation study to explore the safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profile of DSP107 when administered in combination with azacitidine (AZA). Part B is a dose escalation study to explore the safety, efficacy, PK and PD profile of DSP107 when administered in combination with AZA and venetoclax (VEN).
Timeline
- Start
- 2022-01-13
- Primary completion
- 2025-04-23
- Completion
- 2025-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DSP107 | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Background | Venetoclax | Small molecule | 400 mg | — |