A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kahr Medical
• Treatments: Azacitidine; Venetoclax

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

• White Blood Cell count < 20 x 109/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