[M23-477] A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV787 in adult subjects with acute myeloid leukemia (AML)

Okubo Sumiko0 个研究点目标入组 60 人开始时间: 2023年11月25日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•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.).

•- 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.

发起方

Okubo Sumiko