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Purpose

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AK117 (dose 1) in combination with azacitidine 		Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
  • Drug: AK117
    AK117 IV injection
  • Drug: Azacitidine
    Azacitidine SC injection
Experimental
AK117 (dose 2) in combination with azacitidine 		Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
  • Drug: AK117
    AK117 IV injection
  • Drug: Azacitidine
    Azacitidine SC injection
Placebo Comparator
Placebo in combination with azacitidine 		Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
  • Drug: Placebo
    Placebo IV injection
  • Drug: Azacitidine
    Azacitidine SC injection

Recruiting Locations

UCLA Ronald Reagan Medical Center
Los Angeles, California 90095

Rocky Mountain Cancer Centers
Aurora, Colorado 80012

Yale Cancer Center
New Haven, Connecticut 06510

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763

American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Bethesda, Maryland 20817

Maryland Oncology-Columbia
Columbia, Maryland 21044

Washington University School of Medicine in St. Louis
St Louis, Missouri 63110

Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10467

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27514

Gabrail Cancer Center
Canton, Ohio 44718

Ohio State University
Columbus, Ohio 43210

Oncology Associates of Oregon
Eugene, Oregon 97401
Contact:
Luke Fletcher
luke.fletcher@usoncology.com

MUSC Hollings Cancer Center
Charleston, South Carolina 29425

UT Southwestern Medical Center
Dallas, Texas 75390-9065
Contact:
Yazan Madanat
yazan.madanat@utsouthwestern.edu

More Details

Status
Recruiting
Sponsor
Akeso

Study Contact

Wenting Li, MD
(+86)18116403289
wenting01.li@akesobio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.