Evaluating AK117 with Azacitidine for higher-risk Myelodysplastic Syndromes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AK117 in combination with azacitidine in patients who have been newly diagnosed with higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomly assigned to receive either the treatment or a placebo, and their responses will be monitored over time. The study aims to determine if the combination therapy can improve patient outcomes compared to standard treatment. It involves multiple centers to ensure a diverse patient population and robust data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• UCLA Ronald Reagan Medical Center
  Los Angeles, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Aurora, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Mid Florida Hematology and Oncology Center
  Orange City, Florida, United States Recruiting
• American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
  Bethesda, Maryland, United States Recruiting
• Maryland Oncology-Columbia
  Columbia, Maryland, United States Recruiting

Study contacts

• Study coordinator: Wenting Li, MD
• Email: wenting01.li@akesobio.com
• Phone: (+86)18116403289

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bexmarilimab with Azacitidine vs Placebo with Azacitidine in Adults with Higher-Risk MDS

  This phase 2b study tests whether adding bexmarilimab to azacitidine helps adults with newly diagnosed higher-risk myelodysplastic syndromes compared with azacitidine alone.

  Recruiting Phase 2 Faron Pharmaceuticals Ltd · Duarte, California and 34 other locations · NCT07672769

• AZD3632, alone or with other anticancer agents, for advanced blood cancers driven by HOX overexpression

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  Recruiting at 20 sites Phase 1/2 AstraZeneca · Decatur, Illinois and 29 other locations · NCT07155226

• Treatment for elderly patients with higher-risk myelodysplastic syndromes

  This study is testing a new treatment combining two medications followed by a stem cell transplant to see if it helps older patients with higher-risk myelodysplastic syndromes live longer and have fewer complications.

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• Investigating REM-422 for patients with higher risk MDS or relapsed AML

  This study is testing a new oral medication called REM-422 to see if it can help people with higher risk myelodysplastic syndromes or relapsed acute myeloid leukemia feel better and fight their cancer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.