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)

NCT06068868 | Terminated Phase 1 FDA Drug

• 2 other identifiers: M23-4772023-505233-27-00
• Study Type: interventional
• Target: 36
• Locations: 5 countries
• Sites: 24

Brief 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). 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. 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; AML; ABBV-787

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to Approximately 3 Years

• 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.

  Up to approximately 28 Days

Secondary Outcomes (18)

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

  Up to Approximately 1 Year

• Maximum Observed Concentration (Cmax) of ABBV-787

  Up to Approximately 1 Year

• Time to Cmax (Tmax) of ABBV-787

  Up to Approximately 1 Year

• Half-life (t1/2) of ABBV-787

  Up to Approximately 1 Year

• Total Antibody Concentration

  Up to Approximately 1 Year

Study Arms (1)

ABBV-787

EXPERIMENTAL

Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.

Drug: ABBV-787

Interventions

ABBV-787 DRUG

Intravenous (IV) Infusion

ABBV-787

Eligibility Criteria

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

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (24)

City of Hope /ID# 253727

Duarte, California, 91010, United States

Location

University of California Davis Health /ID# 252723

Sacramento, California, 95817, United States

Location

Yale University School of Medicine /ID# 252724

New Haven, Connecticut, 06510, United States

Location

Northwestern Memorial Hospital /ID# 252800

Chicago, Illinois, 60611-2927, United States

Location

University of Chicago Medical /ID# 252764

Chicago, Illinois, 60637, United States

Location

University of Maryland, Baltimore /ID# 253726

Baltimore, Maryland, 21201, United States

Location

Cancer & Hematology Centers /ID# 252803

Grand Rapids, Michigan, 49503, United States

Location

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

New York, New York, 10065-6007, United States

Location

Weill Cornell Medical College /ID# 252516

New York, New York, 10065, United States

Location

University of Pennsylvania /ID# 252789

Philadelphia, Pennsylvania, 19104-5502, United States

Location

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

Austin, Texas, 78704, United States

Location

MD Anderson Cancer Center /ID# 252514

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center /ID# 253730

Seattle, Washington, 98109-1024, United States

Location

Wisconsin Medical Center /ID# 252513

Milwaukee, Wisconsin, 53226, United States

Location

Monash Health - Monash Medical Centre /ID# 253841

Clayton, Victoria, 3168, Australia

Location

Peter MacCallum Cancer Ctr /ID# 252517

Melbourne, Victoria, 3000, Australia

Location

The Chaim Sheba Medical Center /ID# 252913

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 252914

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 252915

Jerusalem, 91120, Israel

Location

National Cancer Center Hospital East /ID# 252519

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Yamagata University Hospital /ID# 254105

Yamagata, Yamagata, 990-9585, Japan

Location

Seoul National University Hospital /ID# 252916

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Asan Medical Center /ID# 253955

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 253956

Seoul, 03722, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

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: September 29, 2023
• First Posted: October 5, 2023
• Study Start: November 13, 2023
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); US (14); JP (2); KR (3); AU (2)