康宁杰瑞制药-B(09966):JSKN033一线治疗晚期宫颈癌的II期临床研究完成首例患者给药

智通财经网
3 hours ago

智通财经APP讯,康宁杰瑞制药-B(09966)发布公告,SKN033(一种由抗人表皮生长因子受体2(“HER2”)双特异性抗体偶联药物(“ADC(s)”)与程序性死亡配体1(“PD-L1”)免疫检查点抑制剂组成的高浓度皮下注射复方制剂)联合铂类化疗联合或不联合贝伐珠单抗一线治疗晚期宫颈癌的一项II期临床研究(研究编号:JSKN033-202)已完成首例患者给药。

JSKN033具备多项显著的差异化优势:“秒钟级”皮下注射极大提升了用药便捷性与依从性;较低的血液学毒性使其成为少数能够与卡铂联用的ADCs之一,为不同肾功能、耐受性及用药习惯的患者提供了更灵活、更安全的用药方案。JSKN033联合铂类及贝伐珠单抗,有望同时发挥HER2 ADC靶向杀伤、免疫激活、抗血管生成与化疗的多重协同抗肿瘤作用,延长疾病控制时间,改善患者生存获益。在早期临床研究中,JSKN033单药在经治晚期宫颈癌患者中已展现出优异疗效和可控安全性,为其一线联合治疗奠定了坚实基础。

JSKN033-202是一项开放、多中心、II期临床研究,旨在评估JSKN033联合铂类化疗联合或不联合贝伐珠单抗一线治疗晚期宫颈癌患者的安全性、有效性及药代动力学╱药效学特征。所有患者将接受JSKN033联合顺铂或卡铂联合或不联合贝伐珠单抗的治疗。铂类药物的选择和是否联用贝伐珠单抗将由研究者根据患者的具体情况决定。该研究的启动有望为晚期宫颈癌患者带来高效、安全、便捷的一线治疗新选择。

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