TABLE 1.
Selected ongoing and completed clinical trials with ATRis.
| ATR inhibitor | Interventions | Cancers | Phase | Study start | Status | NCT number | Result reported |
|---|---|---|---|---|---|---|---|
| Monotherapy | |||||||
| Berzosertib | Alone | Advanced solid tumor, leiomyosarcoma, osteosarcoma | II | 2019 | Completed | NCT03718091 | |
| Ceralasertib | Alone | Relapsed/refractory CLL, PLL or B‐cell lymphoma | I | 2013 | Completed | NCT01955668 | |
| Alone | Head and neck squamous cell carcinoma | I | 2017 | Completed | NCT03022409 | ||
| Alone | Metastatic TNBC | II | 2018 | Recruiting | NCT03801369 | ||
| Alone | Neoadjuvant chemotherapy‐resistant residual TNBC | II | 2019 | Recruiting | NCT03740893 | ||
| Alone | Progressive MDS or CMML | I | 2019 | Recruiting | NCT03770429 | ||
| Alone | Advanced solid tumor | II | 2020 | Recruiting | NCT04564027 | ||
| Elimusertib | Alone | Advanced solid tumor and lymphomas | I | 2017 | Recruiting | NCT03188965 | [40] |
| Alone | Relapsed or refractory solid tumor | I/II | 2021 | Recruiting | NCT05071209 | ||
| IMP9064 | Alone | Advanced solid tumor | I | 2022 | Recruiting | NCT05269316 | |
| ATG‐018 | Alone | Advanced solid tumor and hematological malignancy | I | 2022 | Recruiting | NCT05338346 | |
| ATRN‐119 | Alone | Advanced solid tumor | I/II | 2023 | Recruiting | NCT04905914 | |
| ART0380 | Alone | Advanced solid tumor | II | 2023 | Not yet recruiting | NCT05798611 | |
| Chemotherapy combinations | |||||||
| Berzosertib | Irinotecan, Gemcitabine, Cisplatin, Cisplatin + Gemcitabine or Etoposide or Carboplatin | Advanced solid tumor | I | 2012 | Completed | NCT02157792 | [39,43, 44, 45, 46] |
| Topotecan | Small‐cell cancer | I/II | 2015 | Active, not recruiting | NCT02487095 | [41, 42] | |
| Cisplatin + Gemcitabine | Metastatic urothelial cancer | II | 2016 | Active, not recruiting | NCT02567409 | ||
| Cisplatin + Radiotherapy | Advanced head and neck cancer | I | 2016 | Active, not recruiting | NCT02567422 | ||
| Gemcitabine | Platinum‐resistant recurrent ovarian or primary peritoneal fallopian tube cancer | II | 2016 | Active, not recruiting | NCT02595892 | [49] | |
| Irinotecan | Advanced solid tumor | I | 2016 | Active, not recruiting | NCT02595931 | ||
| Carboplatin + Gemcitabine | Recurrent platinum‐sensitive epithelial ovarian, peritoneal, and fallopian tube cancer | I | 2016 | Active, not recruiting | NCT02627443 | ||
| Cisplatin + Capecitabine + Radiotherapy | Esophageal cancer and other solid tumors | I | 2018 | Completed | NCT03641547 | ||
| Alone, Carboplatin + Paclitaxel | Advanced solid tumor | I | 2018 | Active, not recruiting | NCT03309150 | ||
| Carboplatin | Metastatic castration‐resistant prostate cancer | II | 2018 | Active, not recruiting | NCT03517969 | ||
| Topotecan | Relapsed small‐cell lung cancer | II | 2019 | Active, not recruiting | NCT03896503 | ||
| Irinotecan | Progressive TP53 mutant gastric and gastroesophageal junction cancer | II | 2020 | Active, not recruiting | NCT03641313 | ||
| Topotecan | Relapsed platinum‐resistant SCLC | II | 2021 | Active, not recruiting | NCT04768296 | ||
| Lurbinectedin | Small‐cell cancer and high‐grade neuroendocrine cancer | I/II | 2021 | Recruiting | NCT04802174 | ||
| Sacituzumab govitecan | SCLC, EP‐SCNC and HR‐deficient cancer resistant to PARP Inhibitors | I/II | 2021 | Recruiting | NCT04826341 | ||
| Topotecan | Advanced solid tumor | I | 2022 | Recruiting | NCT05246111 | ||
| Gartisertib | Alone, Carboplatin | Advanced solid tumor | I | 2015 | Completed | NCT02278250 | |
| Tuvusertib | Temozolomide | Advanced solid tumor, hematopoietic and lymphoid tumor | I/II | 2023 | Not yet recruiting | NCT05691491 | |
| Ceralasertib | Paclitaxel | Refractory cancer | I | 2015 | Completed | NCT02630199 | [48] |
| Gemcitabine | Advanced solid tumor | I | 2019 | Recruiting | NCT03669601 | ||
| Trastuzumab deruxtecan | HER2‐positive advanced solid tumor | I | 2021 | Recruiting | NCT04704661 | ||
| Elimusertib | Cisplatin, Cisplatin + Gemcitabine | Advanced solid tumor | I | 2021 | Recruiting | NCT04491942 | |
| Irinotecan, Topotecan | Advanced solid tumor | I | 2021 | Recruiting | NCT04514497 | ||
| FOLFIRI | Metastatic colorectal and gastric/gastroesophageal cancer | I | 2021 | Recruiting | NCT04535401 | ||
| Gemcitabine | Advanced solid tumor | I | 2021 | Recruiting | NCT04616534 | ||
| ART0380 | Alone, Gemcitabine, Irinotecan | Advanced or metastatic solid tumor | I/II | 2021 | Recruiting | NCT04657068 | |
| PARPi combinations | |||||||
| Berzosertib | Veliparib + Cisplatin | Refractory solid tumor | I | 2017 | Completed | NCT02723864 | |
| Gartisertib | Niraparib | PARPi‐resistant recurrent ovarian cancer | I | 2023 | Not yet recruiting | NCT04149145 | |
| Tuvusertib | Alone, Niraparib | Advanced solid tumor | I | 2019 | Recruiting | NCT04170153 | |
| Ceralasertib | Olaparib | Advanced solid tumor | II | 2015 | Terminated | NCT02576444 | [61] |
| Olaparib | Platinum‐refractory extensive‐stage SCLC | II | 2016 | Active, not recruiting | NCT02937818 | ||
| Olaparib | Advanced breast cancer | II | 2016 | Recruiting | NCT03182634 | ||
| Olaparib | Advanced TNBC | II | 2018 | Active, not recruiting | NCT03330847 | ||
| Olaparib | Recurrent ovarian cancer | II | 2018 | Recruiting | NCT03462342 | [60] | |
| Olaparib | Recurrent ovarian, primary peritoneal, or fallopian tube cancer | II | 2018 | Recruiting | NCT03579316 | ||
| Olaparib | Relapsed SCLC | II | 2018 | Completed | NCT03428607 | ||
| Olaparib | Prostate cancer | II | 2019 | Active, not recruiting | NCT03787680 | ||
| Olaparib | IDH1 and IDH2 mutant tumor | II | 2019 | Recruiting | NCT03878095 | ||
| Alone, Olaparib | Gynecological cancer with ARID1A loss or no loss | II | 2019 | Recruiting | NCT04065269 | ||
| Olaparib | Advanced or metastatic germline BRCA mutated breast cancer | II | 2020 | Recruiting | NCT04090567 | ||
| Olaparib | Recurrent osteosarcoma | II | 2020 | Recruiting | NCT04417062 | ||
| Elimusertib | Niraparib | Advanced solid tumor | I | 2020 | Recruiting | NCT04267939 | |
| Camonsertib | Alone, Talazoparib, Gemcitabine | Advanced solid tumor | I/II | 2020 | Recruiting | NCT04497116 | |
| Niraparib, Olaparib | Advanced solid tumor | I/II | 2021 | Recruiting | NCT04972110 | ||
| Olaparib | DDR‐deficient relapsed/refractory CLL | I/II | 2022 | Recruiting | NCT05405309 | ||
| Immunotherapy combinations | |||||||
| Berzosertib | Avelumab + Carboplatin | PARPi‐resistant recurrent ovarian, primary peritoneal, or fallopian tube cancer | I | 2019 | Completed | NCT03704467 | |
| Carboplatin + Gemcitabine + Pembrolizumab | Advanced NSCLC | I/II | 2020 | Recruiting | NCT04216316 | ||
| Avelumab | DDR‐deficient metastatic or unresectable solid tumor | I/II | 2020 | Recruiting | NCT04266912 | ||
| Tuvusertib | M4076, Avelumab | Advanced solid tumor | I | 2022 | Recruiting | NCT05396833 | |
| Ceralasertib | Alone, Carboplatin, Olaparib, AZD5305, Durvalumab | Advanced solid tumor | I/II | 2014 | Recruiting | NCT02264678 | [47] |
| Durvalumab | NSCLC | II | 2015 | Active, not recruiting | NCT02664935 | ||
| Alone, Durvalumab | NSCLC | II | 2017 | Recruiting | NCT03334617 | ||
| Durvalumab | Advanced solid tumor | I | 2018 | Recruiting | NCT05514132 | ||
| Alone, Olaparib, Durvalumab | Advanced solid tumor | II | 2019 | Recruiting | NCT03682289 | ||
| Durvalumab | Gastric cancer and melanoma | II | 2019 | Active, not recruiting | NCT03780608 | [67, 68] | |
| Durvalumab | NSCLC | II | 2019 | Recruiting | NCT03833440 | ||
| Durvalumab | Refractory biliary tract cancer | II | 2020 | Recruiting | NCT04298008 | ||
| Durvalumab, Olaparib | Advanced biliary tract cancer | II | 2020 | Recruiting | NCT04298021 | ||
| Durvalumab | Relapsed SCLC | II | 2020 | Active, not recruiting | NCT04361825 | ||
| Cisplatin or Carboplatin + Etoposide + Durvalumab | Extensive‐stage SCLC | II | 2021 | Recruiting | NCT04699838 | ||
| Durvalumab + Nab‐paclitaxel | Advanced TNBC | II | 2022 | Recruiting | NCT05582538 | ||
| Elimusertib | Pembrolizumab | Advanced solid tumor | I | 2019 | Active, not recruiting | NCT04095273 | |
| Pembrolizumab + Radiotherapy | Recurrent head and neck cancer | I | 2021 | Recruiting | NCT04576091 | ||
| Other combinations | |||||||
| Berzosertib | Whole‐brain radiotherapy | Brain metastases from lung cancer | I | 2016 | Active, not recruiting | NCT02589522 | |
| Radiotherapy | Chemotherapy‐resistant triple‐negative and ER/PR‐positive, HER2‐negative breast cancer | I | 2019 | Recruiting | NCT04052555 | ||
| Tuvusertib | Peposertib | Advanced solid tumor | I | 2023 | Not yet recruiting | NCT05687136 | |
| Ceralasertib | Acalabrutinib | Relapsed/refractory aggressive non‐Hodgkin's lymphoma | I | 2018 | Completed | NCT03527147 | |
| Alone, Acalabrutinib | Relapsed or refractory CLL | I | 2020 | Active, not recruiting | NCT03328273 | ||
| Camonsertib | RP‐6306 | Advanced solid tumor | I | 2021 | Recruiting | NCT04855656 | |
| Radiotherapy | Metastatic cancer with ATM mutation | I/II | 2022 | Recruiting | NCT05566574 | ||
Note: These clinical trial data are from ClinicalTrials.gov (April 2023). Ongoing clinical trials include the status active, not recruiting, recruiting, and not yet recruiting.