Trial Title:
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
NCT ID:
NCT06196203
Condition:
Higher-risk Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK117
Description:
AK117 IV injection
Arm group label:
AK117 (dose 1) in combination with azacitidine
Arm group label:
AK117 (dose 2) in combination with azacitidine
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo IV injection
Arm group label:
Placebo in combination with azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Azacitidine SC injection
Arm group label:
AK117 (dose 1) in combination with azacitidine
Arm group label:
AK117 (dose 2) in combination with azacitidine
Arm group label:
Placebo in combination with azacitidine
Summary:
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Ronald Reagan Medical Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Mid Florida Hematology and Oncology Center
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Facility:
Name:
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Address:
City:
Bethesda
Zip:
20817
Country:
United States
Status:
Recruiting
Facility:
Name:
Maryland Oncology-Columbia
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
MUSC Hollings Cancer Center
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhijian Xiao
Start date:
February 7, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196203
