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)
Phase 1b: Number of participants with dose limiting toxicity (DLT) — At the end of Cycle 1 (each cycle is 28 days) Any untoward medical occurrence in a subject within the first cycle, considered related to the study treatment
Phase 1b/2: Number of participants with adverse events (AEs) — Up to approximately 2 years. Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Phase 1b/2: Composite complete remission rate (CCR) — Time Frame: Up to approximately 2 years The proportion of subjects achieving complete remission (CR) , complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2022 criteria
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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.
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