Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML

Part of paid clinical trials in Duarte, California.

Sponsor
Shattuck Labs, Inc.
Study ID
NCT05275439
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • SL-172154 — DRUG
    The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
  • Azacitidine (AZA) — DRUG
    Chemotherapy drug approved for use in MDS and AML.
  • Venetoclax — DRUG
    Drug approved for use in AML.

Study Details

SL03-Old Hundred(OHD)-104 is designed as a Phase 1a/1b open label, trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of SL-172154 monotherapy as well as in combination with azacitidine or in combination with Azacitidine and Venetoclax.

Key Dates

Start date
Mar 17, 2022
Status verified
Feb 2026
Primary completion
Feb 6, 2025
Completion
Feb 6, 2025

Study Design

Enrollment
106 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SL-172154
    Patients will receive intravenous administration
  • Experimental: SL-172154 + Azacitidine
    Patients will receive intravenous administration of SL-172154 and Azacitidine.
  • Experimental: SL-172154 + Azacitidine + Venetoclax
    Patients will receive intravenous administration of SL-172154 and Azacitidine plus oral venetoclax.
  • Experimental: Part D-Previously untreated HR-MDS 1:1:1 Randomization
    Patients will randomized to receive intravenous administration of the following: * 3 mg/kg SL-172154 + Azacitidine * 1 mg/kg SL-172154 + Azacitidine * Azacitidine Monotherapy

Primary Outcome Measure

Safety Profile of SL-172154 Monotherapy or in Combination With Azacitidine [ Time Frame: From Day 1 to study completion, an average of 2-5 months depending on the treatment arm ]

Locations (16)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UCLA Medical Center-Bowyer Oncology CenterLos AngelesCalifornia90095-
Yale Cancer CenterNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-
The University of ChicagoChicagoIllinois60637-
Norton Cancer InstituteLouisvilleKentucky40202-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-
START MidwestGrand RapidsMichigan49546-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
University of North Carolina, Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
University of Cincinnati Medical CenterCincinnatiOhio45219-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Baylor Scott & White Research InstituteDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-
VCU Massey Cancer CenterRichmondVirginia23219-

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAUCLA Medical Center-Bowyer Oncology Center· Los Angeles, CAYale Cancer Center· New Haven, CTMoffitt Cancer Center· Tampa, FLThe University of Chicago· Chicago, ILNorton Cancer Institute· Louisville, KY

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