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New treatment option for Higher-risk Myelodysplastic Syndromes
Official title A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT06196203
What this study is testing
What is AK117?
AK117 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for higher-risk myelodysplastic syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Ability to undergo the study-required bone marrow sample collection procedures.
You likely can't join if
- 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 treatment clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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 treatment clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment 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...
- Patients who are breastfeeding or plans to breastfeed during the study.
- Other conditions where the investigator considers the patient inappropriate for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Orange City, Florida, United States
- Bethesda, Maryland, United States
- Columbia, Maryland, United States
- St Louis, Missouri, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Canton, Ohio, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Tianjin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Orange City, Florida, United States; Bethesda, Maryland, United States; Columbia, Maryland, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.