drugset / Trial / NCT05275439

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

NCT05275439 ↗

Phase 1 Terminated 106 enrolled Shattuck Labs, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-03-17
Primary completion
2025-02-06
Completion
2025-02-06

Outcome

Missed primary endpoint

Stopped: “Development discontinued”

release “did not translate to clinically meaningful improvements in median overall survival for TP53m AML and HR-MDS patients” shattucklabs.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — Intravenous
Subject SL-172154 Protein / enzyme biologic 1 mg/kg Intravenous
Subject SL-172154 Protein / enzyme biologic 3 mg/kg Intravenous
Subject Venetoclax Small molecule — Oral