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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06068868
Other study ID # M23-477
Secondary ID 2023-505233-27-0
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 13, 2023
Est. completion date October 20, 2029

Study information

Verified date June 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 20, 2029
Est. primary completion date October 20, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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.). Exclusion Criteria: - 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.

Study Design


Intervention

Drug:
ABBV-787
Intravenous (IV) Infusion

Locations

Country Name City State
Australia Monash Medical Centre /ID# 253841 Clayton Victoria
Australia Peter MacCallum Cancer Ctr /ID# 252517 Melbourne Victoria
Israel Hadassah Medical Center-Hebrew University /ID# 252915 Jerusalem Yerushalayim
Israel The Chaim Sheba Medical Center /ID# 252913 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 252914 Tel Aviv Tel-Aviv
Japan National Cancer Center Hospital East /ID# 252519 Kashiwa-shi Chiba
Japan Yamagata University Hospital /ID# 254105 Yamagata-shi Yamagata
Korea, Republic of Seoul National University Hospital /ID# 252916 Seoul
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 253956 Seoul Seoul Teugbyeolsi
United States St. David's South Austin Medical Center /ID# 252790 Austin Texas
United States University of Maryland Medical Center /ID# 253726 Baltimore Maryland
United States Northwestern Memorial Hospital /ID# 252800 Chicago Illinois
United States City of Hope /ID# 253727 Duarte California
United States Cancer & Hematology Centers /ID# 252803 Grand Rapids Michigan
United States MD Anderson Cancer Center /ID# 252514 Houston Texas
United States Yale University School of Medicine /ID# 252724 New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center-Koch Center /ID# 252515 New York New York
United States Weill Cornell Medical College /ID# 252516 New York New York
United States University of California Davis Health /ID# 252723 Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Israel,  Japan,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787 AUC of ABBV-787. Up to Approximately 1 Year
Secondary Maximum Observed Concentration (Cmax) of ABBV-787 Cmax of ABBV-787. Up to Approximately 1 Year
Secondary Time to Cmax (Tmax) of ABBV-787 Tmax of ABBV-787. Up to Approximately 1 Year
Secondary Half-life (t1/2) of ABBV-787 t1/2 of ABBV-787. Up to Approximately 1 Year
Secondary Total Antibody Concentration Total antibody concentration Up to Approximately 1 Year
Secondary Plasma Concentrations of Unconjugated Bromodomain and Extra-terminal Domain (BET) Degrader Payload Plasma concentrations of unconjugated BET degrader payload. Up to Approximately 1 Year
Secondary Antidrug Antibody (ADA) Incidence and concentration of anti-drug antibodies. Up to Approximately 1 Year
Secondary Neutralizing Antibody (nAb) Incidence and concentration of neutralizing antibodies. Up to Approximately 1 Year
Secondary 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. Up to Approximately 1 Year
Secondary Rate of Participants Achieving CR with partial hematologic recovery (CRh) Percentage of participants achieving CRh per ELN 2022. Up to Approximately 1 Year
Secondary Rate of Participants Achieving CR with incomplete hematologic recovery (CRi) Percentage of participants achieving CRi per ELN 2022. Up to Approximately 1 Year
Secondary 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. Up to Approximately 1 Year
Secondary Rate of Participants Achieving Partial Remission (PR) PR is defined as the percentage of participants with PR per ELN 2022. Up to Approximately 1 Year
Secondary 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. Up to Approximately 1 Year
Secondary Number of Participants proceeding to hematopoietic stem cell transplant (HSCT) Number of participants proceeding to HSCT Up to Approximately 3 Years
Secondary 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. Up to Approximately 3 Years
Secondary 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. Up to Approximately 3 Years
Secondary Overall survival (OS) OS is defined as time from first study treatment to death from any cause. Up to Approximately 3 Years
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