Back to search results

A Study of AK117 with Azacitidine for Higher-Risk Myelodysplastic Syndromes

This study is testing a new drug called AK117 in combination with azacitidine for people with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). HR-MDS is a type of blood cancer where the bone marrow doesn't make enough healthy blood cells. Some participants will receive AK117 plus azacitidine, while others will receive a placebo (an inactive substance) plus azacitidine. The main goal is to see how many people achieve a complete remission (when signs of cancer disappear) over about two years. You might be able to join if you are at least 18 years old, have HR-MDS, and meet other health criteria. The study is currently unclear on its recruitment status and plans to enroll about 90 participants.

Study design
This is a Phase 2 study that is randomized, meaning you'll be assigned to a treatment group by chance. It's also double-blind, so neither you nor your doctors will know if you're receiving AK117 or the placebo. It involves multiple medical centers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure complete remission rates for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06196203

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Akeso
~90 participants
Updated 2025-02-11 on ClinicalTrials.gov
What's tested:AK117PlaceboAzacitidine

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete remission rate (CRR)
Measured over Up to approximately 2 years

Conditions

Higher-risk Myelodysplastic Syndromes

Explore related trials

Myelodysplastic Syndrome

Where it's being run

15 sites across 13 states
Maryland2
Ohio2
California1
Colorado1
Connecticut1
Florida1
Missouri1
New York1

Who to contact

Wenting Li, MD
[email protected]
(+86)18116403289
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≥ 18 years old at the time of enrolment.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
Expected life expectancy ≥ 3 months.
Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of \< 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5.
Ability to undergo the study-required bone marrow sample collection procedures.
Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).
Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.
Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 180 days after the last dose of the study treatment.
Unsterilized male patients having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until 180 days after the last dose of study treatment.

Exclusion

MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.
Concurrently participating in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Patients who previously diagnosed with another malignancy and have any evidence of residual disease.
Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.
Patients with any psychiatric or social factor which the investigator deems may interfere with the patient's ability to comply with the requirements of the study.
Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
Patients with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders.
Patients who are breastfeeding or plans to breastfeed during the study.
Other conditions where the investigator considers the patient inappropriate for enrollment.

What this trial measures

  • Complete remission rate (CRR)Up to approximately 2 years

    CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria