Status:
RECRUITING
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Lead Sponsor:
Akeso
Conditions:
Higher-risk Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06196203
Start Date
February 7 2024
End Date
June 1 2026
Last Update
February 11 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
2
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
3
Yale Cancer Center
New Haven, Connecticut, United States, 06510
4
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763