Recruiting
Phase 2

AK117 & Azacitidine

Sponsor:

Akeso

Code:

NCT06196203

Conditions

Higher-risk Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AK117

Placebo

Azacitidine

Study Details

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 higher-risk myelodysplastic syndromes (HR-MDS).

Conditions

Higher-risk Myelodysplastic Syndromes

Study ID

NCT06196203

Start date

Feb 7, 2024

Status verified date

Feb, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AK117 (dose 1) in combination with azacitidine

Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

experimental: AK117 (dose 2) in combination with azacitidine

Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

placebo comparator: Placebo in combination with azacitidine

Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

Interventions

AK117

AK117 IV injection

Placebo

Placebo IV injection

Azacitidine

Azacitidine SC injection

Primary outcome measure

  • Complete remission rate (CRR) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Wenting Li, MD

(+86)18116403289wenting01.li@akesobio.com

Locations

UCLA Ronald Reagan Medical Center

Recruiting

Los Angeles, California, United States, 90095

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)

Recruiting

Bethesda, Maryland, United States, 20817

Maryland Oncology-Columbia

Recruiting

Columbia, Maryland, United States, 21044

Washington University School of Medicine in St. Louis

Recruiting

Saint Louis, Missouri, United States, 63110

Montefiore Einstein Comprehensive Cancer Center

Recruiting

Bronx, New York, United States, 10467

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Oncology Associates of Oregon

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Luke Fletcher

luke.fletcher@usoncology.com

MUSC Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9065

Contacts

Yazan Madanat

yazan.madanat@utsouthwestern.edu

More Information

Sponsor

Akeso

Last update posted

Feb 11, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Akeso on 2025-02-11.