Clinical Trial Finder

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/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.

Part A is a dose escalation study in up to 4 cohorts of patients designed to test the safety and efficacy of DSP107 administered alone and in combination with AZA. The DSP107 starting dose level in Part A will be 0.3 mg/kg based on aggregate safety, PK and PD data from study DSP107_001, an ongoing study exploring the safety of escalating DSP107 doses in patients with advanced solid tumors. There will be a single DLT evaluation period, lasting 28 days, to determine the safety of DSP107 in combination with AZA. The safety, efficacy and PK data will be used to establish a recommended Phase II dose for potential future expansion cohorts and a starting dose for Part B. 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.

Arms

Interventions