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

NCT ID: NCT06387420

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2027-04-30

Brief 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.

Conditions

ACUTE MYELOID LEUKEMIA; AML

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AK117+Azacitidine+Venetoclax

Phase Ib: Subjects will receive: A117: different doses on every 2 weeks, azacitidine: 75 mg/m^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter;

Phase II: Subjects will receive: AK117: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.

Group Type: EXPERIMENTAL

AK117

Intervention Type: DRUG

Subjects receive AK117 intravenously.

Azacitidine

Intervention Type: DRUG

Subjects receive azacitidine subcutaneously.

Venetoclax

Intervention Type: DRUG

Subjects receive venetoclax orally.

Placebo+Azacitidine+Venetoclax

Phase II: Subjects will receive: placebo: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.

Group Type: PLACEBO_COMPARATOR

Azacitidine

Intervention Type: DRUG

Subjects receive azacitidine subcutaneously.

Venetoclax

Intervention Type: DRUG

Subjects receive venetoclax orally.

Placebo

Intervention Type: OTHER

Subjects receive placebo intravenously.

Interventions

AK117

Subjects receive AK117 intravenously.

Intervention Type: DRUG

Azacitidine

Subjects receive azacitidine subcutaneously.

Intervention Type: DRUG

Venetoclax

Subjects receive venetoclax orally.

Intervention Type: DRUG

Placebo

Subjects receive placebo intravenously.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tianjin, , China

Countries

China

Central Contacts

Jie Yang, MD

Role: CONTACT

jie.yang@akdsobio.com

+86(0760)89873999

Facility Contacts

Jianxiang Wang

Role: primary

Other Identifiers

AK117-206

Identifier Type: -

Identifier Source: org_study_id