A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AK117
- Placebo
- Azacitidine
Treatment groups
90 Participants
are divided into 3 treatment groupsLocations
15China
Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college Tianjin China
United States
California
UCLA Ronald Reagan Medical Center90095, Los Angeles United States
Colorado
Rocky Mountain Cancer Centers80012, Aurora United States
Connecticut
Yale Cancer Center06510, New Haven United States
Sponsors and collaborators
Akeso
Lead sponsor
Source ClinicalTrials.gov