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Acute Myeloid LeukemiaPhase 1NCT06068868

Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

A Phase 1 study testing ABBV-787 in people with Acute Myeloid Leukemia, run by AbbVie at 24 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
ABBV-787
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
24 sitesin 5 countries
Study dates
13 Nov 2023to 25 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Laboratory Criteria matching those outlined in the protocol.
  • QT interval corrected for heart rate (QTc) <= 470 msec using Fridericia's correction, and no other clinically significant cardiac abnormalities.
  • Documented diagnosis of non-promyelocytic acute myeloid leukemia (AML), per 2022 European Leukemia Net (ELN) criteria.
  • Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have been treated with up to 3 prior lines of therapy and are refractory to or intolerant of all established AML therapies that are known to clearly provide clinical benefit at the judgement of the investigator.
  • Must have a white blood cell (WBC) count < 25 × 10^9 /L prior to initiation of study drug (Note: Hydroxyurea or leukapheresis is permitted to meet this criterion and for use through Cycle 3 to control for hyperleukocytosis.).

Who cannot join

  • Have received a CD33-targeting therapy within 3 months prior to the first dose of ABBV-787.
  • Stem cell transplant within 3 months prior to first dose of study drug.
  • Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-787.
  • History of documented pneumonitis that required treatment with systemic steroids within the last 6 months, nor any evidence of active pneumonitis.
  • Unresolved toxicity of Grade >= 2 from prior anticancer therapy, or to levels dictated in the eligibility criteria, with the exception of alopecia.
  • Known active severe or poorly controlled acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

United States14 sites

  • St. David's South Austin Medical Center /ID# 252790

    Austin, Texas, 78704

  • University of Maryland, Baltimore /ID# 253726

    Baltimore, Maryland, 21201

  • Northwestern Memorial Hospital /ID# 252800

    Chicago, Illinois, 60611-2927

  • University of Chicago Medical /ID# 252764

    Chicago, Illinois, 60637

  • City of Hope /ID# 253727

    Duarte, California, 91010

  • Cancer & Hematology Centers /ID# 252803

    Grand Rapids, Michigan, 49503

  • MD Anderson Cancer Center /ID# 252514

    Houston, Texas, 77030

  • Wisconsin Medical Center /ID# 252513

    Milwaukee, Wisconsin, 53226

  • Yale University School of Medicine /ID# 252724

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252515

    New York, New York, 10065-6007

  • Weill Cornell Medical College /ID# 252516

    New York, New York, 10065

  • University of Pennsylvania /ID# 252789

    Philadelphia, Pennsylvania, 19104-5502

  • University of California Davis Health /ID# 252723

    Sacramento, California, 95817

  • Fred Hutchinson Cancer Research Center /ID# 253730

    Seattle, Washington, 98109-1024

Other trials in United States

Israel3 sites

  • Hadassah Medical Center-Hebrew University /ID# 252915

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 252913

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 252914

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

South Korea3 sites

  • Seoul National University Hospital /ID# 252916

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 253955

    Seoul, Seoul Teugbyeolsi, 05505

  • Yonsei University Health System Severance Hospital /ID# 253956

    Seoul, 03722

Other trials in South Korea

Australia2 sites

  • Monash Health - Monash Medical Centre /ID# 253841

    Clayton, Victoria, 3168

  • Peter MacCallum Cancer Ctr /ID# 252517

    Melbourne, Victoria, 3000

Other trials in Australia

Japan2 sites

  • National Cancer Center Hospital East /ID# 252519

    Kashiwa-shi, Chiba, 277-8577

  • Yamagata University Hospital /ID# 254105

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-787 in Adult Subjects With Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed.

ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide.

Read more

Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

Being tested
ABBV-787
Keywords
Acute Myeloid Leukemia, AML, ABBV-787
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.

  • ABBV-787Drug

    Intravenous (IV) Infusion

Study groups in NCT06068868
Study groupRoleWhat they receive
ABBV-787ExperimentalParticipants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.
Receives: Drug: ABBV-787

What is being measured

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

  1. Number of Participants with Adverse Events (AE)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 3 Years

  2. Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

    Measured: Up to approximately 28 Days

Secondary outcomes (18)

  1. Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787

    AUC of ABBV-787.

    Measured: Up to Approximately 1 Year

  2. Maximum Observed Concentration (Cmax) of ABBV-787

    Cmax of ABBV-787.

    Measured: Up to Approximately 1 Year

  3. Time to Cmax (Tmax) of ABBV-787

    Tmax of ABBV-787.

    Measured: Up to Approximately 1 Year

  4. Half-life (t1/2) of ABBV-787

    t1/2 of ABBV-787.

    Measured: Up to Approximately 1 Year

  5. Total Antibody Concentration

    Total antibody concentration

    Measured: Up to Approximately 1 Year

  6. Plasma Concentrations of Unconjugated Bromodomain and Extra-terminal Domain (BET) Degrader Payload

    Plasma concentrations of unconjugated BET degrader payload.

    Measured: Up to Approximately 1 Year

  7. Antidrug Antibody (ADA)

    Incidence and concentration of anti-drug antibodies.

    Measured: Up to Approximately 1 Year

  8. Neutralizing Antibody (nAb)

    Incidence and concentration of neutralizing antibodies.

    Measured: Up to Approximately 1 Year

  9. Percentage of Participants Achieving Complete Remission (CR)

    CR is assessed by the European Leukemia Net (ELN). ELN defines refractory disease as the inability to attain complete remission (CR) or CR with incomplete hematologic recovery (CRi) after two courses of intensive induction treatment.

    Measured: Up to Approximately 1 Year

  10. Rate of Participants Achieving CR with partial hematologic recovery (CRh)

    Percentage of participants achieving CRh per ELN 2022.

    Measured: Up to Approximately 1 Year

  11. Rate of Participants Achieving CR with incomplete hematologic recovery (CRi)

    Percentage of participants achieving CRi per ELN 2022.

    Measured: Up to Approximately 1 Year

  12. Rate of Participants Achieving Composite CR (CR, CRh, or CRi)

    Composite CR is defined as the percentage of participants with composite CR per ELN 2022.

    Measured: Up to Approximately 1 Year

  13. Rate of Participants Achieving Partial Remission (PR)

    PR is defined as the percentage of participants with PR per ELN 2022.

    Measured: Up to Approximately 1 Year

  14. Duration of Response (DOR)

    DOR is defined for participants with CR, CRh, CRi, or PR as the time from the participant's initial response of CR, CRh, CRi, or PR per investigator review according to ELN 2022 criteria to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to Approximately 1 Year

  15. Number of Participants proceeding to hematopoietic stem cell transplant (HSCT)

    Number of participants proceeding to HSCT

    Measured: Up to Approximately 3 Years

  16. Event-free Survival (EFS)

    EFS is defined as the time from the date of the first study treatment to the date of treatment failure, or hematologic relapse from either CR, CRh, or CRi, or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 3 Years

  17. Relapse free survival (RFS)

    RFS is defined for participants achieving CR, CRh, or CRi as time from the date of achievement of remission (CR, CRh, or CRi) until the date of hematologic relapse or death from any cause.

    Measured: Up to Approximately 3 Years

  18. Overall survival (OS)

    OS is defined as time from first study treatment to death from any cause.

    Measured: Up to Approximately 3 Years

Timeline

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

  1. First posted5 Oct 2023
  2. Study start13 Nov 2023
  3. Primary completion25 Feb 2025
  4. Study completion25 Feb 2025

Why it stopped: Strategic considerations

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068868
Sponsor's protocol ID
M23-477
Other IDs
2023-505233-27-00, 2023
Status last verified
Mar 2025
First submitted
29 Sep 2023
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-787 in people with Acute Myeloid Leukemia, run by AbbVie at 24 sites in 5 countries.

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 6 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: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Israel, South Korea, Australia, Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AE) (time frame: Up to Approximately 3 Years). The study lists 2 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 NCT06068868.

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 6 Mar 2025.

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