ArticleBritish journal of cancer2026
Safety and efficacy of ceralasertib, an ATR kinase inhibitor, combined with olaparib: dose escalation in advanced solid tumours and dose expansion in advanced breast cancer.
Article in British journal of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02264678 (A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.), which is not on this map. Not yet cited in PubMed.
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A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.
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Abstract
backgroundCeralasertib, an ATR inhibitor, is known to exacerbate replication stress induced by the PARP inhibitor (PARPi) olaparib, with the combination having the potential to overcome PARPi resistance in the clinic. This modular Phase 1 study evaluated the combination in advanced solid tumours, including breast cancer.
methodsDose escalation of ceralasertib alone (Part A1) or with olaparib (Part A2) in patients with all solid tumours was followed by expansion in PARPi-naïve patients with BRCA1/2 m HER2-negative breast cancer (Part B3) or BRCA1/2 wt triple-negative breast cancer (Part B4).
resultsOverall, 142 patients were treated. No dose-limiting toxicities occurred in Part A1. Based on haematological safety in Part A2, the combination recommended Phase 2 dose was ceralasertib 160 mg once-daily, days 1-7, plus olaparib 300 mg twice-daily continuously (28-day cycles). In Parts B3 and B4, 36/37 (97.3%) and 24/25 (96.0%) patients had treatment-emergent adverse events (grade ≥3: 16/37 [43.2%], 9/25 [36.0%]; leading to discontinuation: 2/37 [5.4%], 1/25 [4.0%]), and 7 (18.9%) and 3 (12.0%) required ceralasertib dose reductions. Objective response rates were: Part A1, 0%; Part A2, 16.4% (n = 10/61); Part B3, 37.8% (n = 14/37); and Part B4, 0%.
conclusionIn PARPi-naïve patients with BRCA1/2 m HER2-negative breast cancer, ceralasertib-olaparib had generally manageable safety and demonstrated preliminary antitumour activity. TRIAL REGISTRATION NUMBER: NCT02264678.
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