NCT04937166TerminatedPhase 1
A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies
An Open-label Phase Ib Study of DSP107 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Reason given: Slow enrolment
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 6 Jun 2021
- Start date
- 13 Jan 2022
- Primary completion date
- 23 Apr 2025
- Lead sponsor
- Kahr Medical
- NCT number
- NCT04937166
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy
- Immune-mediated adverse reaction that required discontinuation of prior immunotherapy
- Prior organ allografts (such as renal transplant) requiring active immunosuppression
- Treatment with systemic immunostimulatory within 4 weeks prior to initiation of study treatment
- Treatment with any CD47/SIRPα targeting agent or immune agonists
- Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment
Other illness
- 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
- Active graft versus host disease
- Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
- Active Hepatitis B or C infection
- History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease
Other
- Acute Promyelocytic leukemia
- Symptomatic central nervous system (CNS) leukemia or patients with poorly controlled CNS leukemia
- Pregnant or breast feeding or planning to become pregnant while enrolled in the study
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope | Duarte | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center, Department of Leukemia | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.