NCT05424380

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	GSK3745417	GSK3745417 will be administered

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2022-06-21
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

10 sites across 5 countries: Canada, Germany, Italy, Netherlands, Spain