A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
NCT06387420 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2024-04-29
Summary
This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.
Conditions
- ACUTE MYELOID LEUKEMIA; AML
Interventions
- DRUG
-
AK117
Subjects receive AK117 intravenously.
- DRUG
-
Subjects receive azacitidine subcutaneously.
- DRUG
-
Subjects receive venetoclax orally.
- OTHER
-
Placebo
Subjects receive placebo intravenously.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-29
- Primary Completion
- 2026-04-30
- Completion
- 2027-04-30
Countries
- China
Study Locations
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