NCT05209152

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

A Phase 1 Study of AMG 176 as Monotherapy and in Combination With Azacitidine in Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia (HR-MDS/CMML).

Detailed description

This study is a Phase 1 clinical trial designed to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of HR-MDS/CMML. Participants will be treated with intravenous (IV) AMG 176 and IV or subcutaneous (SC) azacitidine.

Conditions

• Higher Risk Myelodysplastic Syndrome
• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
DRUG	AMG 176	Administered as an intravenous (IV) infusion.
DRUG	Azacitidine	Administered as an IV infusion or subcutaneous (SC) injection.

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2022-01-26
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study