NCT06196203 A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
| NCT ID | NCT06196203 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akeso |
| Condition | Higher-risk Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-02-07 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06196203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Higher-risk Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06196203 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06196203 currently recruiting?
Yes, NCT06196203 is actively recruiting participants. Contact the research team at wenting01.li@akesobio.com for enrollment information.
Where is the NCT06196203 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, New Haven, United States, Orange City, United States and 11 additional locations.
Who is sponsoring the NCT06196203 clinical trial?
NCT06196203 is sponsored by Akeso. The trial plans to enroll 90 participants.