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NCT04937166 | RECRUITING | Acute Myeloid Leukemia

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies
Sponsor:

Havoc medical

Brief 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 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).

Condition or disease

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Chronic Myelomonocytic Leukemia

Intervention/treatment

DSP107

Azacitidine

Venetoclax

Phase

PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label Phase Ib Study of DSP107 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Actual Study Start Date : 2022-01-13
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies

Location Details

NCT04937166

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How to Participate

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Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, Texas

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

Houston, Texas, United States, 77030