A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Sponsor
Akeso
Study ID
NCT06387420
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • ACUTE MYELOID LEUKEMIA; AML

Eligibility Criteria

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

Interventions

  • AK117 — DRUG
    Subjects receive AK117 intravenously.
  • Azacitidine — DRUG
    Subjects receive azacitidine subcutaneously.
  • Venetoclax — DRUG
    Subjects receive venetoclax orally.
  • Placebo — OTHER
    Subjects receive placebo intravenously.

Study Details

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.

Key Dates

Start date
Apr 29, 2024
Status verified
Apr 2024
Primary completion
Apr 30, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: AK117+Azacitidine+Venetoclax
    Phase Ib: Subjects will receive: A117: different doses on every 2 weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter; Phase II: Subjects will receive: AK117: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.
  • Placebo Comparator: Placebo+Azacitidine+Venetoclax
    Phase II: Subjects will receive: placebo: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.

Primary Outcome Measure

Phase 1b: Number of participants with dose limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts