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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Akeso
Study ID
NCT06196203
Phase
PHASE2
Status
Recruiting
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Conditions

  • Higher-risk Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK117 — DRUG
    AK117 IV injection
  • Placebo — DRUG
    Placebo IV injection
  • Azacitidine — DRUG
    Azacitidine SC injection

Study Details

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).

Key Dates

Start date
Feb 7, 2024
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
UCLA Ronald Reagan Medical CenterLos AngelesCalifornia90095-
Rocky Mountain Cancer CentersAuroraColorado80012-
Yale Cancer CenterNew HavenConnecticut06510-
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)BethesdaMaryland20817-
Maryland Oncology-ColumbiaColumbiaMaryland21044-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10467-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
Gabrail Cancer CenterCantonOhio44718-
Ohio State UniversityColumbusOhio43210-
Oncology Associates of OregonEugeneOregon97401
Luke Fletcher
[email protected]
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
UT Southwestern Medical CenterDallasTexas75390-9065
Yazan Madanat
[email protected]

Find similar trials in Los Angeles, CA

By research site
UCLA Ronald Reagan Medical Center· Los Angeles, CARocky Mountain Cancer Centers· Aurora, COYale Cancer Center· New Haven, CTMid Florida Hematology and Oncology Center· Orange City, FLAmerican Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)· Bethesda, MDMaryland Oncology-Columbia· Columbia, MD

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