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)

Acute Myeloid Leukemia Clinical Trial

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)

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
• 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
• 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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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