RECRUITING

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

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Conditions

Higher-risk Myelodysplastic Syndromes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-02-07
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06196203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years old at the time of enrolment.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
  3. * Expected life expectancy ≥ 3 months.
  4. * 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.
  5. * Ability to undergo the study-required bone marrow sample collection procedures.
  6. * Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).
  7. * 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.
  8. * 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.
  9. * 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.
  1. * MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
  2. * Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.
  3. * 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.
  4. * Patients who previously diagnosed with another malignancy and have any evidence of residual disease.
  5. * Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.
  6. * 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.
  7. * Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
  8. * 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.
  9. * Patients who are breastfeeding or plans to breastfeed during the study.
  10. * Other conditions where the investigator considers the patient inappropriate for enrollment.

Contacts and Locations

Study Contact

Wenting Li, MD
CONTACT
(+86)18116403289
wenting01.li@akesobio.com

Study Locations (Sites)

UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
United States
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Bethesda, Maryland, 20817
United States
Maryland Oncology-Columbia
Columbia, Maryland, 21044
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
Montefiore Einstein Comprehensive Cancer Center
Bronx, New York, 10467
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
Ohio State University
Columbus, Ohio, 43210
United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Akeso

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-02-07
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Higher-risk Myelodysplastic Syndromes