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Clinical Trials in China / NCT06387420
Starting soon Phase 1/2

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

NCT06387420 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 1/2
Started
2024-04-29
Last updated
2024-04-29

Condition(s) studied

ACUTE MYELOID LEUKEMIA; AML

Investigational drug(s) / intervention(s)

AK117 →Azacitidine →Venetoclax →Placebo

AK117: Subjects receive AK117 intravenously.

Azacitidine: Subjects receive azacitidine subcutaneously.

Venetoclax: Subjects receive venetoclax orally.

Placebo: Subjects receive placebo intravenously.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin China

On this site

📄 Venclexta (venetoclax) drug profile →

More Akeso trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06387420 on ClinicalTrials.gov ↗ ← All trials in China