A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
NCT ID: NCT06196203
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-02-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK117 (dose 1) in combination with azacitidine
Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
AK117
AK117 IV injection
Azacitidine
Azacitidine SC injection
AK117 (dose 2) in combination with azacitidine
Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
AK117
AK117 IV injection
Azacitidine
Azacitidine SC injection
Placebo in combination with azacitidine
Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
Placebo
Placebo IV injection
Azacitidine
Azacitidine SC injection
Interventions
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AK117
AK117 IV injection
Placebo
Placebo IV injection
Azacitidine
Azacitidine SC injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Bethesda, Maryland, United States
Maryland Oncology-Columbia
Columbia, Maryland, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Zhijian Xiao
Role: primary
Other Identifiers
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AK117-205
Identifier Type: -
Identifier Source: org_study_id
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