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NCT05209152 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Amgen.

Terminated
Registry status
Phase 1
Development phase
7
Enrollment target

NCT05209152: Clinical Trial Phase 1 study, sponsored by Amgen.

NCT05209152 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05209152, a Phase 1 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study 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).

Primary Outcome

DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to AMG 176: Grade 3 or higher non-hematological or a Grade 4 hematologic adverse event (AE) during the DLT observation period in Part 1. CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.

Interventions

  • DRUG Azacitidine
  • DRUG AMG 176

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2022-11-14
Est. Completion 2023-12-19
Phase Phase 1
Amgen

558 total trials

Why NCT05209152 stopped before completion

NCT05209152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.

NCT05209152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05209152 about?

NCT05209152 is a clinical study titled "AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia". 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).

What is the current status of trial NCT05209152?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-11-14. Estimated completion is 2023-12-19.

What interventions are being tested in trial NCT05209152?

The interventions under investigation include: Azacitidine (DRUG), AMG 176 (DRUG).

Who is sponsoring clinical trial NCT05209152?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05209152's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05209152, the US trial registry maintained by the National Library of Medicine. NCT05209152 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.