Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

Summary

This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab. The fourth module will investigate the effect of food on ceralasertib absorption and the effect of ceralasertib on ECG parameter. The fifth module to be investigated is ceralasertib with AZD5305.

Timeline

Start

2014-10-31

Primary completion

2025-03-04

Completion

2026-06-30

Publications

• Lopez JS, Harrington KJ, Im SA, Lee KW, Postel-Vinay S, Thomas JS, Lukashchuk N, Willis SE, Irurzun-Arana I, Webb B, Nehra J, Lau A, Loembe AB, Dean E, Krebs MG. Phase 1 study of ceralasertib, an ATR kinase inhibitor, in combination with durvalumab in patients with recurrent or metastatic NSCLC or HNSCC. Br J Cancer. 2026 Jun;134(11):1568-1579. doi: 10.1038/s41416-026-03408-y. Epub 2026 Mar 31.
• Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.

Drugs

Indications

No indication recorded.