AzTrials
AzTrials

ACUTE MYELOID LEUKEMIA; AMLPhase 1/2NCT06387420

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

A Phase 1/2 study testing AK117, Azacitidine and Venetoclax in people with ACUTE MYELOID LEUKEMIA; AML, run by Akeso at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ACUTE MYELOID LEUKEMIA; AML
What is being tested?
AK117, Azacitidine and Venetoclax
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
29 Apr 2024to Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Yang, MD contact

+86(0760)89873999

jie.yang@akdsobio.com

China1 site

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

    Tianjin

    Jianxiang Wang

Other trials in China

About this study

Official title: 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.

Being tested
AK117, Azacitidine, Venetoclax, Placebo
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK117Drug

    Subjects receive AK117 intravenously.

  • AzacitidineDrug

    Subjects receive azacitidine subcutaneously.

  • VenetoclaxDrug

    Subjects receive venetoclax orally.

  • PlaceboOther

    Subjects receive placebo intravenously.

Study groups in NCT06387420
Study groupRoleWhat they receive
AK117+Azacitidine+VenetoclaxExperimentalPhase 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.
Receives: Drug: AK117; Drug: Azacitidine; Drug: Venetoclax
Placebo+Azacitidine+VenetoclaxPlacebo comparatorPhase 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.
Receives: Drug: Azacitidine; Drug: Venetoclax; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Number of participants with dose limiting toxicity (DLT)

    Any untoward medical occurrence in a subject within the first cycle, considered related to the study treatment

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Phase 1b/2: Number of participants with adverse events (AEs)

    Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment

    Measured: Up to approximately 2 years.

  3. Phase 1b/2: Composite complete remission rate (CCR)

    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

    Measured: Time Frame: Up to approximately 2 years

Secondary outcomes (11)

  1. Overall response rate (ORR)

    The proportion of subjects with recorded response per European LeukemiaNet (ELN) 2022

    Measured: Up to approximately 2 years

  2. Time to response (TTR)

    Time from cycle 1 day 1(C1D1) to the first recorded response

    Measured: Up to approximately 2 years

  3. Time to CCR (TTCCR)

    Time from C1D1 to the first recorded CR, CRh or CRi

    Measured: Up to approximately 2 years

  4. Duration of response (DoR)

    Time from the first recorded response until disease progression, relapse, or death due to any cause, whichever occurs first

    Measured: Up to approximately 2 years

  5. Duration of CCR (DoCCR)

    Time from the first recorded CR, CRh or CRi until disease progression, relapse, or death due to any cause, whichever occurs first

    Measured: Up to approximately 2 years

  6. Rate of CCR Without Minimal Residual Disease (CCR MRD-)

    The proportion of subjects achieving CR, CRh or CRi with MRD-negative status per ELN 2022 criteria.

    Measured: Up to approximately 2 years

  7. Event-free survival (EFS)

    Time from C1D1 until disease progression, relapse, or death due to any cause, whichever occurs first

    Measured: Up to approximately 2 years

  8. Overall survival (OS)

    Up to approximately 2 years

    Measured: The time from C1D1 until death due to any cause

  9. Peak of Serum Concentration (Cmax)

    Maximal serum concentrations of AK117 in individual subjects at different time points after AK117 administration

    Measured: Up to approximately 2 years

  10. Anti-drug antibody (ADA)

    Number of subjects with detectable anti-drug antibodies

    Measured: Up to approximately 2 years

  11. Receptor occupancy (RO)

    CD47 occupancy rate on peripheral blood T cells and red blood cells before and after AK117 administration

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start29 Apr 2024 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06387420
Sponsor's protocol ID
AK117-206
Status last verified
Apr 2024
First submitted
24 Apr 2024
Last updated
29 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK117, Azacitidine and Venetoclax in people with ACUTE MYELOID LEUKEMIA; AML, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Yang, MD (+86(0760)89873999, jie.yang@akdsobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of participants with dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06387420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in