What's the purpose of this trial?
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).
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Acute Promyelocytic leukemia
* 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/SIRPĪ± 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
Additional Trial Information
Phase 1
Enrollment: 36 patients (estimated)
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