[M23-477] 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)

JRCT ID: jRCT2021230042

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia
• Date of first enrollment: 25/11/2023
• Target sample size: 60
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Drug: ABBV-787
Intravenous (IV) Infusion

Outcome(s)

Primary Outcome

Number of Participants with Adverse Events (AE)
Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)

Secondary Outcome

AUC of ABBV-787
Cmax of ABBV-787
Tmax of ABBV-787
t1/2 of ABBV-787
Total antibody concentration
Plasma concentrations of unconjugated BET degrader payload.
Antidrug Antibody (ADA)
Neutralizing Antibody (nAb)
Percentage of Participants Achieving Complete Remission (CR)
Rate of Participants Achieving CR with partial hematologic recovery (CRh)
Rate of Participants Achieving CR with incomplete hematologic recovery (CRi)
Rate of Participants Achieving Composite CR (CR, CRh, or CRi)
Rate of Participants Achieving Partial Remission (PR)
Duration of Response (DOR)
Number of Participants proceeding to hematopoietic stem cell transplant (HSCT)
Event-free Survival (EFS)
Relapse free survival (RFS)
Overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 x 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.).

Exclude 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 Information

• Primary Sponsor: Okubo Sumiko
• Secondary ID(s): NCT06068868