An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients With Advanced Solid Malignancies

Phase 1 Completed 12 enrolled AstraZeneca

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ceralasertib in Japanese patients with advanced solid malignancies. Cycle 0 duration is 4 days and each cycle from Cycle 1 has a duration of 28 days.

Timeline

Start: 2022-06-09
Primary completion: 2023-08-17
Completion: 2024-03-12

Publications

Kuboki Y, Matsubara N, Nakajima H, Fujisawa T, Koyama T, Sato J, Katsuya Y, Kmieciak A, Slade D, Iwata K, Takahashi Y, Nii M, Murayama K, Kawata T, Kawasumi H, Yamamoto N. Ceralasertib, an ATR kinase inhibitor, as monotherapy in Japanese patients with advanced solid malignancies: Results from a phase 1 study. Invest New Drugs. 2025 Dec;43(6):1235-1246. doi: 10.1007/s10637-025-01592-x. Epub 2025 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceralasertib	Small molecule	160 mg	Oral
Subject	Ceralasertib	Small molecule	240 mg	Oral

Indications

No indication recorded.