A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies
NCT ID: NCT04937166
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
25 participants
INTERVENTIONAL
2022-01-13
2025-10-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part B is a dose escalation study in 2 cohorts of patients that will test the safety and efficacy of DSP107 in combination with AZA and VEN. The starting dose for Part B will be at least one dose level lower than the DSP107 dose selected in Part A as being safe and effective in combination with AZA. Once a safe, effective dose has been established in Part B, a recommended phase 2 dose for patients with newly diagnosed AML will be agreed with the FDA at an End-of-Phase 1 meeting.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DSP107 in combination with azacitidine or azacitidine plus venetoclax.
DSP107 will be administered by intravenous infusion once weekly during each 28-day cycle to all patients in this study.
Azacitidine (75 mg/m2/day) will be administered subcutaneously or intravenously for the first 7 days of every cycle.
Patients enrolled in Part B only will also receive venetoclax. During Cycle 1, venetoclax will be dose escalated daily to the goal dose of 400 mg daily. Patients will receive 100 mg on Day 1, 200 mg on Day 2 and 400 mg on Day 3 and onwards.
DSP107
DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
Azacitidine
Azacitidine is an analog of the pyrimidine nucleoside cytidine.
Venetoclax
Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DSP107
DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
Azacitidine
Azacitidine is an analog of the pyrimidine nucleoside cytidine.
Venetoclax
Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* White Blood Cell count \< 20 x 10\^9/L.
* Adequate organ function
* Relapsed/refractory AML or MDS/CMML patients who have failed up to 2 prior therapeutic regimens.
Exclusion Criteria
* Symptomatic central nervous system (CNS) leukemia or patients with poorly controlled CNS leukemia
* Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy
* Immune-mediated adverse reaction that required discontinuation of prior immunotherapy
* Past or current history of autoimmune disease or immune deficiency
* History of severe interstitial lung disease or severe pneumonitis or active pneumonitis
* Clinically significant and poorly compensated liver disease
* Prior organ allografts (such as renal transplant) requiring active immunosuppression
* Active graft versus host disease
* Treatment with systemic immunostimulatory within 4 weeks prior to initiation of study treatment
* Treatment with any CD47/SIRPα targeting agent or immune agonists
* Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
* Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment
* Active Hepatitis B or C infection
* History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease
* Pregnant or breast feeding or planning to become pregnant while enrolled in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kahr Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope
Duarte, California, United States
The University of Texas MD Anderson Cancer Center, Department of Leukemia
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSP107_002
Identifier Type: -
Identifier Source: org_study_id