A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

NCT04980885 | Active Not Recruiting Phase 1

• 1 other identifier: AK117-104
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Composite complete remission rate （complete remission + complete remission with incomplete count recovery）

  Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria.

  Approximately 6 months

• Number of participants with adverse events (AEs)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Up to approximately 2 years.

Secondary Outcomes (6)

• Rate of CR Without Minimal Residual Disease (CR MRD-)

  Approximately 6 months

• Duration of complete response (DoCR)

  Approximately 6 months

• Overall Survival

  Up to death or end of study

• Event-Free Survival (EFS)

  Up to end of study

• Maximum observed concentration (Cmax) of AK117

  Up to 2 years.

Study Arms (1)

AK117+Azacitidine

EXPERIMENTAL

Phase Ib: Subjects will receive different doses of A117 in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28 day cycle; Phase II: Subjects will receive AK117 at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28-day cycle.

Drug: AK117; Drug: Azacitidine

Interventions

AK117 DRUG

Subjects receive AK117 intravenously.

AK117+Azacitidine

Azacitidine DRUG

Subjects receive Azacitidine subcutaneously.

AK117+Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 28, 2021
• Study Start: August 13, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

CN (1)