康宁杰瑞JSKN016注射液启动Ib/II期临床适应症为局部晚期或转移性HR阳性、HER2阴性乳腺癌

新浪财经01-04

药物临床试验登记与信息公示平台数据显示，江苏康宁杰瑞生物制药有限公司的JSKN016联合D - 0502在局部晚期或转移性HR阳性、HER2阴性乳腺癌患者中的多中心、开放标签、Ib/II期随机对照临床研究已启动。临床试验登记号为CTR20255271，首次公示信息日期为2026年1月4日。该药物剂型为注射液和片剂，JSKN016注射液用法为静脉输注，按4mg/kg剂量给药，Q2W组每14天为1周期...

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0502在局部晚期或转移性HR阳性、HER2阴性乳腺癌患者中的多中心、开放标签、Ib/II期随机对照临床研究已启动。临床试验登记号为CTR20255271，首次公示信息日期为2026年1月4日。该药物剂型为注射液和片剂，JSKN016注射液用法为静脉输注，按4mg/kg剂量给药，Q2W组每14天为1周期，于第1天给药；Q3W组每21天为1周期，于第1天给药。D - 0502片剂用法为口服，固定剂量200mg，每日一次。本次试验主要目的为评价联合用药安全性、耐受性、剂量限制性毒性及初步抗肿瘤活性；次要目的为进一步评估抗肿瘤活性、总体安全性和耐受性，评估药代动力学特征和免疫原性。JSKN016注射液为生物制品，适应症为局部晚期或转移性HR阳性、HER2阴性乳腺癌。此类乳腺癌是雌激素或孕激素受体阳性、人表皮生长因子受体2阴性的乳腺癌，晚期可出现转移症状，诊断依靠病理活检及免疫组化。本次试验主要终点指标包括Ib期剂量限制性毒性发生情况、安全性和耐受性；II期客观缓解率。次要终点指标包括疾病控制率、缓解持续时间、临床获益率、无进展生存期及关键时间点PFS率；总生存期及关键时间点OS率；安全性与耐受性指标；药代动力学参数；抗药物抗体发生率、抗体滴度及中和抗体发生率。目前，该实验状态为进行中（尚未招募），目标入组人数60人。风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不构成个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核验，因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问，请联系biz@staff.sina.com.cn。责任编辑：小浪快报","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2601003867","isCrawlerRequest":true}

康宁杰瑞JSKN016注射液启动Ib/II期临床 适应症为局部晚期或转移性HR阳性、HER2阴性乳腺癌

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康宁杰瑞JSKN016注射液启动Ib/II期临床适应症为局部晚期或转移性HR阳性、HER2阴性乳腺癌