An Open-label Phase Ib Study of DSP107 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Description

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).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 per

Trial Eligibility

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 * Pregnant or breast feeding or planning to become pregnant while enrolled in the study

Study Info

Interventions

Locations Recruiting

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