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Monoclonal Antibodies

AK117 + Azacitidine for Myelodysplastic Syndrome

Phase 2
Recruiting
Research Sponsored by Akeso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years

Summary

This trial is looking at whether a new drug called AK117, when given with azacitidine, is effective and safe for treating patients with a specific type of blood disorder called higher-risk myel

Who is the study for?
This trial is for adults over 18 with newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) and less than 20% bone marrow or blood blasts. Participants need an ECOG score of 0-2, indicating they can perform daily activities, and must expect to live at least three more months. Women of childbearing age must test negative for pregnancy and use contraception, as should men with partners who could become pregnant.
What is being tested?
The study tests AK117 combined with Azacitidine versus a placebo plus Azacitidine in patients with HR-MDS. It's a Phase 2 trial where participants are randomly assigned to either the treatment group or the control group without knowing which one they're in (double-blind). The goal is to assess how well AK117 works and its safety when given alongside Azacitidine.
What are the potential side effects?
Potential side effects from AK117 may include immune system reactions, infusion-related responses similar to allergic reactions, fatigue, nausea, bleeding issues due to low platelet counts, and increased risk of infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete remission rate (CRR)
Secondary study objectives
Anti-drug antibody (ADA)
Duration of CR (DoCR)
Duration of response (DoR)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AK117 (dose 2) in combination with azacitidineExperimental Treatment2 Interventions
Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
Group II: AK117 (dose 1) in combination with azacitidineExperimental Treatment2 Interventions
Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
Group III: Placebo in combination with azacitidinePlacebo Group2 Interventions
Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AK117
2020
Completed Phase 1
~90
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

AkesoLead Sponsor
117 Previous Clinical Trials
22,237 Total Patients Enrolled
1 Trials studying Myelodysplastic Syndromes
190 Patients Enrolled for Myelodysplastic Syndromes
~45 spots leftby Jan 2026
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