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

Part of paid clinical trials in Duarte, California.

Sponsor
Kahr Medical
Study ID
NCT04937166
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jan 13, 2022
Status verified
Nov 2025
Primary completion
Apr 23, 2025
Completion
Oct 24, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: DSP107 in combination with azacitidine or azacitidine plus venetoclax.
    DSP107 will be administered by intravenous infusion once weekly during each 28-day cycle to all patients in this study. Azacitidine (75 mg/m2/day) will be administered subcutaneously or intravenously for the first 7 days of every cycle. Patients enrolled in Part B only will also receive venetoclax. During Cycle 1, venetoclax will be dose escalated daily to the goal dose of 400 mg daily. Patients will receive 100 mg on Day 1, 200 mg on Day 2 and 400 mg on Day 3 and onwards.

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: Duration of the study, estimated to be 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
The University of Texas MD Anderson Cancer Center, Department of LeukemiaHoustonTexas77030-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAThe University of Texas MD Anderson Cancer Center, Department of Leukemia· Houston, TX

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