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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

Organization

Kahr Medical


Primary Outcome

Adverse Events (AEs)


Outcome Timeframe Duration of the study, estimated to be 12 months

NCTID NCT04937166

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2022-01-13

Completion Date 2025-06

Enrollment Target 36

Interventions

BIOLOGICAL DSP107

DRUG Azacitidine

DRUG Venetoclax

Locations Recruiting

City of Hope

United States, California, Duarte


The University of Texas MD Anderson Cancer Center, Department of Leukemia

United States, Texas, Houston


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

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