药捷安康-B(02617):替恩戈替尼联合氟维司群用于经治失败的HR+/HER2-复发或转移性乳腺癌患者的II期临床完成首例患者给药

智通财经
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智通财经APP讯,药捷安康-B(02617)发布公告,本公司核心产品替恩戈替尼(Tinengotinib, TT-00420)联合氟维司群用于经治失败的激素受体阳性(HR+)且人表皮生长因子受体2阴性或低表达(HER2-)的复发或转移性乳腺癌患者的II期临床研究,于近日完成首例患者给药。

本试验为在中国开展的一项评价替恩戈替尼联合氟维司群注射液用于经治失败的HR+╱HER2-的复发或转移性乳腺癌患者的安全性、疗效及药代动力学的开放、多中心、II期临床研究。该试验的主要目标人群为既往接受过内分泌治疗及 CDK4/6抑制剂治疗等标准治疗后失败的HR+╱HER2-复发或转移性乳腺癌患者,旨在探索替恩戈替尼与氟维司群联合疗法的临床应用价值,为该类耐药乳腺癌患者提供新的治疗选择。

乳腺癌是全球女性高发的恶性肿瘤之一,HR+╱HER2-亚型占乳腺癌患者总数的约70%,该类患者在经标准治疗后易出现耐药复发,临床亟需新的有效治疗方案。替恩戈替尼早期临床研究结果表明,其单药在经多种治疗的HR+╱HER2 乳腺癌患者中展现出令人鼓舞的临床效果,支持其与内分泌治疗联用的进一步研发。

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