Ceralasertib, an ATR kinase inhibitor, as monotherapy in Japanese patients with advanced solid malignancies: Results from a phase 1 study.

ABSTRACT:

Background

Ceralasertib is an oral, selective, and potent inhibitor of ATR serine/threonine kinase, a key protein involved in cell cycle checkpoint regulation and DNA damage response. We report preliminary safety, tolerability, and pharmacokinetic data of ceralasertib monotherapy in Japanese patients with advanced solid tumors.

Methods

In this phase 1, open-label study, patients orally received ceralasertib twice daily 240 mg on days 1-7 (Cohort 1) or 160 mg on days 1-14 (Cohort 2) of a 28-day cycle, respectively; both cohorts also received a single ceralasertib dose 4 days before Cycle 1. Patients were aged ≥ 18 years with solid malignancies refractory to standard therapies or for which no standard therapy exists. The primary objective was to determine ceralasertib safety;

SUBMITTER: Kuboki Y 

PROVIDER: S-EPMC12753540 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature