Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes
Led by Akeso · Updated on 2025-02-11
90
Participants Needed
15
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of AK117 combined with azacitidine compared to placebo with azacitidine in adults with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers to better understand treatment options for this condition. Participants receive either one of two doses of AK117 intravenously along with azacitidine given as a subcutaneous injection on days 1 to 7 of each 28-day cycle, or a placebo intravenously combined with the same azacitidine regimen. The study compares these groups to assess different dosing effects and safety profiles over time. During the study, participants will undergo regular assessments including bone marrow sample collections and blood tests to monitor response and safety. Researchers will measure outcomes such as complete remission rate, overall response, time to response, duration of response, event-free survival, and overall survival for up to about two years. Patient safety and adverse events will also be closely tracked throughout the study period.
CONDITIONS
Brief Title
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Expected life expectancy of at least 3 months
- Newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS) with less than 20% blasts in bone marrow or peripheral blood and an overall IPSS-R score of 3.5 or higher
- Ability to undergo required bone marrow sample collection procedures
- Suitable venous access for study-required blood sampling including pharmacokinetics and immunogenicity
- Female patients of childbearing age must have negative serum pregnancy test before randomization and negative urine pregnancy test on dosing day
- Female patients of childbearing potential with unsterilized male partners must agree to use highly effective contraception from screening until 180 days after last dose
- Unsterilized male patients with female partners of childbearing potential must agree to use effective contraception from screening until 180 days after last dose
You will not qualify if you...
- Myelodysplastic syndromes evolving from pre-existing myeloproliferative neoplasm or myelodysplastic/myeloproliferative neoplasms
- Prior treatment with CD47 or SIRPα-targeting agents
- Currently participating in another interventional clinical study, except observational or follow-up periods
- Previous diagnosis of another malignancy with any residual disease evidence
- Known allergy to study drug components or severe hypersensitivity to other monoclonal antibodies
- Psychiatric or social factors interfering with study compliance
- Current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite oral antihypertensive therapy
- Known cardiopulmonary disease such as unstable angina, significant arrhythmia, severe heart failure (NYHA Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders
- Breastfeeding or plans to breastfeed during the study
- Other conditions deemed inappropriate for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 2 years
Participants receive AK117 or placebo intravenously in combination with azacitidine subcutaneously.
Azacitidine given on Days 1 to 7 every 4 weeks with AK117 or placebo dosing schedule depending on assigned group
Trial Site Locations
Total: 15 locations
1
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
5
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Bethesda, Maryland, United States, 20817
Actively Recruiting
6
Maryland Oncology-Columbia
Columbia, Maryland, United States, 21044
Actively Recruiting
7
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10467
Actively Recruiting
9
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
13
MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
14
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9065
Actively Recruiting
15
Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college
Tianjin, China
Actively Recruiting
Research Team
W
Wenting Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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