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).
Additional locations may be listed on ClinicalTrials.gov for NCT04937166.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationKahr Medical
