Trial reportCancer research communications2026
Ceralasertib Monotherapy in Patients with ATM-Altered Advanced Solid Tumors or Metastatic Castration-Resistant Prostate Cancer: Data from the Phase IIa PLANETTE Study.
Trial report in Cancer research communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- A Phase II Study of Berzosertib in Combination with Carboplatin Compared with Docetaxel with Carboplatin in Metastatic Castration-Resistant Prostate Cancer.Cancer research communications · 2026Trial
- Synthetic lethality in cancer: mechanisms, therapeutic exploitation and clinical translation.Signal transduction and targeted therapy · 2026Review
- Radiogenomics and the DNA damage response: opportunities for biomarker-guided radiosensitization in pancreatic cancer.Frontiers in oncology · 2026Review
Corrections and comments
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Authors and funding
22 authors.
Funding
Abstract
purposeCeralasertib is an oral ataxia telangiectasia and Rad3-related (ATR) inhibitor with preclinical activity in ataxia-telangiectasia mutated (ATM)-altered cancers. The phase IIa PLANETTE study evaluated ceralasertib in previously treated advanced solid tumors (cohort A) or metastatic castration-resistant prostate cancer (cohort B) with ATM alterations (ATM mutations and/or ATM protein deficiency). PATIENTS AND
methodsPatients received ceralasertib 160 mg twice daily on days 1 to 14 of a 28-day cycle. Efficacy was evaluated in patients with centrally confirmed ATM alterations. The primary endpoint was objective response rate (ORR; cohort A) or composite response rate (CRR: radiographic response, prostate-specific antigen response, or circulating tumor cell conversion; cohort B). Secondary endpoints included progression-free survival (PFS) and safety.
resultsCohorts A and B included 30 and 15 patients, respectively. ORR (cohort A) was 7.1% [80% confidence interval (CI), 1.9-17.9; n = 2/28]: one complete response ongoing at 14.1 months (breast cancer) and one partial response ongoing at 7.4 months (endometrial cancer). CRR (cohort B) was 7.7% (80% CI, 0.8-28.6; n = 1/13). In patients with centrally confirmed ATM protein loss, the ORR was 18.2% (80% CI, 4.9-41.5; n = 2/11) and CRR was 0% (80% CI, 0-28; n = 0/7). The median PFS was 3.7 months in each cohort (cohort A, 80% CI, 1.9-5.6; cohort B, 80% CI, 1.9-not calculable). Grade ≥3 adverse events (AE) occurred in 50% of cohort A and 53.3% of cohort B patients. The most common AEs overall were asthenia/fatigue, nausea, and anemia.
conclusionsCeralasertib monotherapy was tolerated; however, responses were limited. Alternative patient selection and combination treatments are being explored. SIGNIFICANCE: In the phase IIa PLANETTE study in advanced/metastatic ATM-altered cancers, ceralasertib 160 mg twice daily (days 1-14, 28-day cycle) was tolerated; objective responses were limited, corroborating previous findings with ATR inhibitors in ATM-deficient tumors. Optimizing biomarker-based patient selection beyond ATM deficiency represents a key aspect of future ATR inhibitor development.
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