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Monoclonal Antibodies

AK117 (dose 2) in combination with azacitidine for Myelodysplastic Syndromes

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission rate (CRR)

Secondary outcome measures

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

~100

Azacitidine

2012

Completed Phase 3

~1440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AkesoLead Sponsor

102 Previous Clinical Trials

18,077 Total Patients Enrolled

1 Trials studying Myelodysplastic Syndromes

190 Patients Enrolled for Myelodysplastic Syndromes

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of AK117 (at dose 1) with azacitidine received approval from the FDA?

"The safety evaluation conducted by our team at Power rates AK117 (at dose 1) combined with azacitidine as a level 2 on the scale. This assessment reflects existing safety data without conclusive evidence of effectiveness, characteristic of Phase 2 trials."

Answered by AI

What is the current number of subjects enrolled in this medical study?

"Yes, the details on clinicaltrials.gov indicate that this investigation is currently seeking participants. The trial was initially posted on February 7th, 2024 and its most recent update was made on March 22nd, 2024. There are openings for enrollment of up to 90 individuals across two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

2024. "A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06196203.

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