A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies
NCT04937166 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-11-10
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).
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Chronic Myelomonocytic Leukemia
Interventions
- BIOLOGICAL
-
DSP107
DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
- DRUG
-
Azacitidine is an analog of the pyrimidine nucleoside cytidine.
- DRUG
-
Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor
Sponsors & Collaborators
-
Kahr Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-13
- Primary Completion
- 2025-04-23
- Completion
- 2025-10-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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