Kevin Harrington, Shigehisa Kitano, Valentina Gambardella, Eileen E Parkes, Irene Moreno, Guzman Alonso, Toshihiko Doi, David Berz, Martin E Gutierrez, Natalia Fernandez, Michael Schmohl, José Barrueco, Patricia LoRusso
{"title":"开放标签、Ia期研究STING激动剂BI 1703880联合ezabenlimab治疗晚期实体瘤患者。","authors":"Kevin Harrington, Shigehisa Kitano, Valentina Gambardella, Eileen E Parkes, Irene Moreno, Guzman Alonso, Toshihiko Doi, David Berz, Martin E Gutierrez, Natalia Fernandez, Michael Schmohl, José Barrueco, Patricia LoRusso","doi":"10.1080/14796694.2024.2441107","DOIUrl":null,"url":null,"abstract":"<p><p>BI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors. The study utilizes an innovative lead-in design; all patients receive BI 1703880 monotherapy in Cycle 1 and combination therapy from Cycle 2. The primary endpoint is dose-limiting toxicities during the maximum tolerated dose evaluation period. Results will inform the future development of BI 1703880 for treatment of metastatic or recurrent malignancies.<b>Clinical Trial number:</b> NCT05471856.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"195-200"},"PeriodicalIF":3.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792791/pdf/","citationCount":"0","resultStr":"{\"title\":\"Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors.\",\"authors\":\"Kevin Harrington, Shigehisa Kitano, Valentina Gambardella, Eileen E Parkes, Irene Moreno, Guzman Alonso, Toshihiko Doi, David Berz, Martin E Gutierrez, Natalia Fernandez, Michael Schmohl, José Barrueco, Patricia LoRusso\",\"doi\":\"10.1080/14796694.2024.2441107\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>BI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors. The study utilizes an innovative lead-in design; all patients receive BI 1703880 monotherapy in Cycle 1 and combination therapy from Cycle 2. The primary endpoint is dose-limiting toxicities during the maximum tolerated dose evaluation period. Results will inform the future development of BI 1703880 for treatment of metastatic or recurrent malignancies.<b>Clinical Trial number:</b> NCT05471856.</p>\",\"PeriodicalId\":12672,\"journal\":{\"name\":\"Future oncology\",\"volume\":\" \",\"pages\":\"195-200\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792791/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Future oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14796694.2024.2441107\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/16 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14796694.2024.2441107","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/16 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
BI 1703880是一种新型干扰素基因刺激剂(STING)激动剂,具有临床前抗肿瘤活性。由于STING激活可上调肿瘤细胞中的程序性死亡配体1和人白细胞抗原,因此BI 1703880与抗程序性细胞死亡蛋白1抗体(如ezabenlimab)联合使用可能会提高疗效。这项首次人体i期研究(NCT05471856)正在评估BI 1703880联合ezabenlimab在晚期实体瘤患者中的应用。本研究采用创新的导入设计;所有患者在第1周期接受BI 1703880单药治疗,在第2周期接受联合治疗。主要终点是最大耐受剂量评估期间的剂量限制性毒性。结果将为BI 1703880用于治疗转移性或复发性恶性肿瘤的未来开发提供信息。临床试验编号:NCT05471856。
Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors.
BI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors. The study utilizes an innovative lead-in design; all patients receive BI 1703880 monotherapy in Cycle 1 and combination therapy from Cycle 2. The primary endpoint is dose-limiting toxicities during the maximum tolerated dose evaluation period. Results will inform the future development of BI 1703880 for treatment of metastatic or recurrent malignancies.Clinical Trial number: NCT05471856.
期刊介绍:
Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community.
The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.