For Healthcare Professionals

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  2. White Blood Cell count < 20 x 10^9/L.
  3. Adequate organ function
  4. Relapsed/refractory AML or MDS/CMML patients who have failed up to 2 prior therapeutic regimens.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Acute Promyelocytic leukemia
  2. Symptomatic central nervous system (CNS) leukemia or patients with poorly controlled CNS leukemia
  3. Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy
  4. Immune-mediated adverse reaction that required discontinuation of prior immunotherapy
  5. Past or current history of autoimmune disease or immune deficiency
  6. History of severe interstitial lung disease or severe pneumonitis or active pneumonitis
  7. Clinically significant and poorly compensated liver disease
  8. Prior organ allografts (such as renal transplant) requiring active immunosuppression
  9. Active graft versus host disease
  10. Treatment with systemic immunostimulatory within 4 weeks prior to initiation of study treatment
  11. Treatment with any CD47/SIRPα targeting agent or immune agonists
  12. Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
  13. Received live, attenuated vaccine within 4 weeks prior to first dose of study treatment
  14. Active Hepatitis B or C infection
  15. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease
  16. Pregnant or breast feeding or planning to become pregnant while enrolled in the study
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +972-50-6396356Email iconEmail Study Center

Study’s details


Contition

Acute Myeloid Leukemia,Myelodysplastic Syndromes,Chronic Myelomonocytic Leukemia

Age (in years)

18+

Phase

Phase 1

Participants needed

36

Est. Completion Date

Dec 31, 2024

Treatment type

Interventional


Sponsor

Kahr Medical

ClinicalTrials.gov identifier

NCT04937166

Study number

DSP107_002

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