Tests AK117 with azacitidine and venetoclax in acute myeloid leukemia
Tests AK117 with two other drugs in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukemia (AML) to test AK117 given with azacitidine and venetoclax.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- AML diagnosed by WHO 2022 criteria. Performance status (ECOG) of 0 to 3; 0 to 2 for people aged 75 or older.
- Earlier treatment
- No earlier Bcl-2 inhibitor, anti-CD47 or anti-SIRPα treatment. No earlier allogeneic stem cell transplant. No demethylating drugs for earlier MDS.
Main reasons for not taking part
- Acute promyelocytic leukemia, BCR-ABL1-positive AML, myeloid sarcoma, MPAL, or accelerated or blast phase of chronic myeloid leukemia
- Leukemia in the central nervous system
- Favorable-risk cytogenetics such as t(8;21), inv(16), t(16;16) or t(15;17)
- Another cancer diagnosed earlier or any sign of leftover disease
- Serious heart, liver, kidney or metabolic disease, such as unstable angina or heart failure class III or IV
Read by machine on 12 November 2026.
Where in China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjin, ChinaContact: Jianxiang WangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Akeso
- Trial code
- NCT06387420
- Record updated
- 29 April 2024
- Original description
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.Read full original descriptionShow less
A Phase 1b/2 Study of AK117 (Anti-CD47 Antibody) in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
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.
Inclusion: 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: 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; 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; 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; 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).