Acute Myeloid Leukemia Clinical Trial
A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies
Summary
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 as monotherapy and 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).
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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