NCT04937166

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

An Open-label Phase Ib Study of DSP107 for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Kahr Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	DSP107	DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
DRUG	Azacitidine	Azacitidine is an analog of the pyrimidine nucleoside cytidine.
DRUG	Venetoclax	Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor

Timeline

• Start date: 2022-01-13
• Primary completion: 2025-04-23
• Completion: 2025-10-24
• First posted: 2021-06-23
• Last updated: 2025-11-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study