NCT05275439

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

An Open-Label Phase 1a/1b Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combination With Azacitidine or With Azacitidine and Venetoclax for the Treatment of Subjects With Higher-Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Shattuck Labs, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This Phase 1a/1b study is an open label, multicenter trial in subjects with higher-risk (i.e., intermediate, high or very high risk by IPSS-R) MDS or AML. The study is designed to evaluate the safety, PK, pharmacodynamic effects, and preliminary anti tumor activity of SL-172154 monotherapy and SL-1712154 administered with either Azacitidine or Azacitidine and Venetoclax. Subjects will receive SL-172154 as monotherapy or administered with Azacitidine with or without Venetoclax until documented disease progression, unacceptable toxicity or intolerance, withdrawal of consent, or the subject meets other criteria for discontinuation (whichever occurs first). Part D: Safety and efficacy will be further explored in Part D. Approximately 60 subjects with previously untreated higher-risk MDS will be randomized equally into 3 groups: 3.0 mg/kg SL-172154+azacitidine, 1.0 mg/kg SL-172154+azacitidine and azacitidine monotherapy. Patients will be stratified based on the TP53 mutation status (TP53m vs TP53wt) and bone marrow blast count at study entry (\<5% vs ≥5%).

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	SL-172154	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.
DRUG	Azacitidine (AZA)	Chemotherapy drug approved for use in MDS and AML.
DRUG	Venetoclax	Drug approved for use in AML.

Timeline

• Start date: 2022-03-17
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2022-03-11
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

23 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study