Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 4:47 PM
Study NCT ID:
NCT06196203
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2023-12-24', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate (CRR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The proportion of subjects with recorded response per IWG 2023'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time from the randomization to the first recorded response'}, {'measure': 'Time to CR (TTCR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time from the randomization to the first recorded CR'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time from the first recorded response until disease relapse or progression or death due to any cause, whichever occurs first'}, {'measure': 'Duration of CR (DoCR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time from the first recorded CR until disease relapse or progression or death due to any cause, whichever occurs first'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Time from randomization until transformation to AML or death due to any cause, whichever occurs first'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time from randomization until death due to any cause'}, {'measure': 'Number of subjects with adverse events (AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'An AE is any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment'}, {'measure': 'Pharmacokinetic characteristics', 'timeFrame': 'Up to approximately 2 years', 'description': 'Serum concentrations of AK117 in individual subjects at different time points after AK117 administration'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number of subjects with detectable anti-drug antibodies'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Higher-risk Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old at the time of enrolment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n* Expected life expectancy ≥ 3 months.\n* 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.\n* Ability to undergo the study-required bone marrow sample collection procedures.\n* Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).\n* 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.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN).\n* Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.\n* 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.\n* Patients who previously diagnosed with another malignancy and have any evidence of residual disease.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.\n* 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.\n* Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* 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.\n* Patients who are breastfeeding or plans to breastfeed during the study.\n* Other conditions where the investigator considers the patient inappropriate for enrollment."}, 'identificationModule': {'nctId': 'NCT06196203', 'briefTitle': 'A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AK117-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK117 (dose 1) in combination with azacitidine', 'description': 'Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously', 'interventionNames': ['Drug: AK117', 'Drug: Azacitidine']}, {'type': 'EXPERIMENTAL', 'label': 'AK117 (dose 2) in combination with azacitidine', 'description': 'Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously', 'interventionNames': ['Drug: AK117', 'Drug: Azacitidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in combination with azacitidine', 'description': 'Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously', 'interventionNames': ['Drug: Placebo', 'Drug: Azacitidine']}], 'interventions': [{'name': 'AK117', 'type': 'DRUG', 'description': 'AK117 IV injection', 'armGroupLabels': ['AK117 (dose 1) in combination with azacitidine', 'AK117 (dose 2) in combination with azacitidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo IV injection', 'armGroupLabels': ['Placebo in combination with azacitidine']}, {'name': 'Azacitidine', 'type': 'DRUG', 'description': 'Azacitidine SC injection', 'armGroupLabels': ['AK117 (dose 1) in combination with azacitidine', 'AK117 (dose 2) in combination with azacitidine', 'Placebo in combination with azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Ronald Reagan Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid Florida Hematology and Oncology Center', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Maryland Oncology-Columbia', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Montefiore Einstein Comprehensive Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luke Fletcher', 'role': 'CONTACT', 'email': 'luke.fletcher@usoncology.com'}], 'facility': 'Oncology Associates of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MUSC Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390-9065', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yazan Madanat', 'role': 'CONTACT', 'email': 'yazan.madanat@utsouthwestern.edu'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijian Xiao', 'role': 'CONTACT'}], 'facility': 'Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wenting Li, MD', 'role': 'CONTACT', 'email': 'wenting01.li@akesobio.com', 'phone': '(+86)18116403289'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}