Clinical trial NCT04980885: A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia
Official title: A Phase Ib/II Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open label, phase Ib/II study. All patients are diagnosed with 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 in subjects with AML.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years (at the time consent is obtained).
* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
* 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.
* Patient with AML diagnosed according to WHO 2016 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:

* Patient has acute promyelocytic leukemia.
* Patient has known active central nervous system (CNS) involvement with AML.
* 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 2, 2021 for AML.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has undergone major surgery within 30 days of Study Day 1.
* Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Previous allogeneic hematopoietic stem cell transplant (allo-HSCT) .
* Prior treatment with any anti-CD47 or anti-SIRPα (signal regulatory protein alpha) agent.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
* Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
* Patient with known allergy or hypersensitivity to AK117, azacitidine or any of their components.

Primary outcomes:
measure: Composite complete remission rate （complete remission + complete remission with incomplete count recovery）
timeFrame: Approximately 6 months
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 2 years.
Secondary outcomes:
measure: Rate of CR Without Minimal Residual Disease (CR MRD-)
timeFrame: Approximately 6 months
measure: Duration of complete response (DoCR)
timeFrame: Approximately 6 months
measure: Overall Survival
timeFrame: Up to death or end of study
measure: Event-Free Survival (EFS)
timeFrame: Up to end of study
measure: Maximum observed concentration (Cmax) of AK117
timeFrame: Up to 2 years.
measure: Anti-drug antibodies (ADA)
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital，Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: