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Not yet recruiting NCT06387420

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

Phase I / Phase II Interventional ACUTE MYELOID LEUKEMIA; AML

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK117, Azacitidine, Venetoclax, Placebo.
Who it may be relevant to
Registry conditions: ACUTE MYELOID LEUKEMIA; AML. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b/2 Study of AK117 (Anti-CD47 Antibody) in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Overview

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.

Interventions

  • Drug AK117
    Subjects receive AK117 intravenously.
  • Drug Azacitidine
    Subjects receive azacitidine subcutaneously.
  • Drug Venetoclax
    Subjects receive venetoclax orally.
  • Other Placebo
    Subjects receive placebo intravenously.

Primary outcome measures

  • Phase 1b: Number of participants with dose limiting toxicity (DLT) [Time frame: At the end of Cycle 1 (each cycle is 28 days)]
  • Phase 1b/2: Number of participants with adverse events (AEs) [Time frame: Up to approximately 2 years.]
  • Phase 1b/2: Composite complete remission rate (CCR) [Time frame: Time Frame: Up to approximately 2 years]
Secondary outcome measures (11)
  • Overall response rate (ORR) [Time frame: Up to approximately 2 years]
  • Time to response (TTR) [Time frame: Up to approximately 2 years]
  • Time to CCR (TTCCR) [Time frame: Up to approximately 2 years]
  • Duration of response (DoR) [Time frame: Up to approximately 2 years]
  • Duration of CCR (DoCCR) [Time frame: Up to approximately 2 years]
  • Rate of CCR Without Minimal Residual Disease (CCR MRD-) [Time frame: Up to approximately 2 years]
  • Event-free survival (EFS) [Time frame: Up to approximately 2 years]
  • Overall survival (OS) [Time frame: The time from C1D1 until death due to any cause]
  • Peak of Serum Concentration (Cmax) [Time frame: Up to approximately 2 years]
  • Anti-drug antibody (ADA) [Time frame: Up to approximately 2 years]
  • Receptor occupancy (RO) [Time frame: Up to approximately 2 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old at the time of enrolment.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0\~3, and 0\~2 are required for subjects ≥75 years old.
  • Has a life expectancy of at least 12 weeks.
  • Diagnosed as AML diagnosed according to WHO 2022 criteria.
  • Has adequate organ function.
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion criteria

  • Diagnosed with acute promyelocytic leukemia, BCR-ABL1-positive AML, myeloid sarcoma, mixed phenotype acute leukemia (MPAL), accelerated phase or blast crisis of Chronic Myeloid Leukemia.
  • has central nervous system leukemia (CNSL).
  • Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 6, 2023 for AML.
  • Previously diagnosed with another malignancy or have any evidence of residual disease.
  • Previous allogeneic hematopoietic stem cell transplant (allo-HSCT).
  • Prior treatment with any B-cell lymphoma 2 (Bcl-2) inhibitors, anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
  • Use strong or moderate cytochrome P450 (CYP) 3A inducers systemically within one week prior to enrollment, or currently require long-term treatment with a moderate to strong CYP3A inducer.
  • Previously diagnosed with MDS and treated with demethylating drugs.
  • 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.
  • Other conditions where the investigator considers the patient inappropriate for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & P — Tianjin

Identifiers

NCT: NCT06387420 · AK117-206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗