<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/HitchmedPhaseI-shutterstock_2463696267-3-428x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="428" height="241" original-src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/HitchmedPhaseI-shutterstock_2463696267-3-428x241.jpg"/></p>
<p>该 I/IIa 期研究将评估 HMPL-A251 作为单一药物在无法切除的晚期或转移性 HER2 表达固体肿瘤成人患者中的疗效。来源：PeopleImages / Shutterstock.com。</p>
<p>Hutchmed 已启动其全球 I 期临床开发计划，针对首个类磷脂酰肌醇 3 激酶（PI3K）/类磷脂酰肌醇 3 激酶相关蛋白激酶（PIKK）- 人表皮生长因子受体 2（HER2）抗体靶向治疗结合物（ATTC）HMPL-A251。</p>
<p>该研究的临床试验地点位于中国和美国。最近，首位患者在中国接受了剂量治疗。</p>
<p>该首个人体 I/IIa 期多中心开放标签临床研究将评估 HMPL-A251 作为单一药物在无法切除的晚期或转移性 HER2 表达固体肿瘤成人患者中的疗效。</p>
<p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="130" height="183" original-src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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<p>该临床研究分为两个部分：I 期剂量递增阶段和 IIa 期剂量扩展与优化阶段。</p>
<p>其主要目标是评估 HMPL-A251 的耐受性和安全性，并在 I 期期间确定最大耐受剂量（MTD）和/或推荐扩展剂量（RDE）。</p>
<p>在 IIa 期部分，研究将进一步评估初步疗效、安全性在 RDE 下，并确定 II 期（RP2D）或 III 期（RP3D）的推荐剂量。</p>
<p>次要结果指标包括评估初步抗肿瘤活性、药代动力学特征和治疗的免疫原性。</p>
<p>该平台的初始项目组基于一种高效且选择性强的 PI3K/PIKK 抑制剂载体。</p>
<p>通过将该载体附加到抗 HER2 抗体上，该分子被认为能够将靶向通路抑制直接输送到表达 HER2 的肿瘤细胞中。</p>
<p>该公司的 ATTC 平台被描述为一种下一代精准肿瘤学方法，结合了单克隆抗体与小分子抑制剂载体，以实现双重作用机制。</p>
<p>在 2025 年 3 月，Hutchmed 完成了招募 其多中心 II 期试验，针对具有成纤维生长因子受体 2 融合或重排的肝内胆管癌（IHCC）患者的 fanregratinib（HMPL-453）治疗。</p>
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和黄医药

<p>和黄医药已启动 HMPL-A251 的全球 I 期临床开发项目，这是一种首创的 PI3K/PIKK-HER2 抗体靶向治疗结合物。该研究将在中国和美国进行，旨在评估该疗法在晚期 HER2 表达肿瘤成人患者中的效果。该试验包括 I 期剂量递增和 IIa 期剂量扩展阶段，重点关注安全性、耐受性和疗效。ATTC 平台将单克隆抗体与小分子抑制剂结合，以实现精准肿瘤治疗</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/HitchmedPhaseI-shutterstock_2463696267-3-428x241.jpg" alt="" original-src="https://www.worldpharmaceuticals.net/wp-content/uploads/sites/12/2025/12/HitchmedPhaseI-shutterstock_2463696267-3-428x241.jpg"/></p>
<p>The Phase I/IIa study will assess HMPL-A251 as a single agent in adults with unresectable, advanced, or metastatic HER2-expressing solid tumours. Credit: PeopleImages / Shutterstock.com.</p>
<div class="lb-trans"><p>该 I/IIa 期研究将评估 HMPL-A251 作为单一药物在无法切除的晚期或转移性 HER2 表达固体肿瘤成人患者中的疗效。来源：PeopleImages / Shutterstock.com。</p>
</div><p>Hutchmed has commenced its worldwide Phase I clinical development programme for a first-in-class phosphoinositide 3-kinase (PI3K) / phosphoinositide 3-kinase-related protein kinase (PIKK)-human epidermal growth factor receptor 2 (HER2) antibody-targeted therapy conjugate (ATTC), HMPL-A251.</p>
<div class="lb-trans"><p>Hutchmed 已启动其全球 I 期临床开发计划，针对首个类磷脂酰肌醇 3 激酶（PI3K）/类磷脂酰肌醇 3 激酶相关蛋白激酶（PIKK）- 人表皮生长因子受体 2（HER2）抗体靶向治疗结合物（ATTC）HMPL-A251。</p>
</div><p>Clinical trial sites for this study are located in China and the US. Recently, the first patient received a dose in China.</p>
<div class="lb-trans"><p>该研究的临床试验地点位于中国和美国。最近，首位患者在中国接受了剂量治疗。</p>
</div><p>The first-in-human, Phase I/IIa, multi-centre, open-label clinical study will assess HMPL-A251 as a single agent in adults with unresectable, advanced, or metastatic HER2-expressing solid tumours.</p>
<div class="lb-trans"><p>该首个人体 I/IIa 期多中心开放标签临床研究将评估 HMPL-A251 作为单一药物在无法切除的晚期或转移性 HER2 表达固体肿瘤成人患者中的疗效。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png" alt="" original-src="https://hubspot-pmisites.pantheonsite.io/techmonitor/wp-content/themes/goodlife-wp-B2B/assets/images/icons/Module.png"/></p>
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</div><p>The clinical study is divided into two parts: a Phase I dose escalation stage and a Phase IIa dose expansion and optimisation stage.</p>
<div class="lb-trans"><p>该临床研究分为两个部分：I 期剂量递增阶段和 IIa 期剂量扩展与优化阶段。</p>
</div><p>Its main aims are to assess the tolerability and safety of HMPL-A251 and to identify the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) during Phase I.</p>
<div class="lb-trans"><p>其主要目标是评估 HMPL-A251 的耐受性和安全性，并在 I 期期间确定最大耐受剂量（MTD）和/或推荐扩展剂量（RDE）。</p>
</div><p>In the Phase IIa segment, the study will further evaluate preliminary efficacy, safety at RDEs, and determine the recommended dose for Phase II (RP2D) or Phase III (RP3D).</p>
<div class="lb-trans"><p>在 IIa 期部分，研究将进一步评估初步疗效、安全性在 RDE 下，并确定 II 期（RP2D）或 III 期（RP3D）的推荐剂量。</p>
</div><p>Secondary outcome measures include evaluation of preliminary antitumour activity, the pharmacokinetic profile, and the immunogenicity of the therapy.</p>
<div class="lb-trans"><p>次要结果指标包括评估初步抗肿瘤活性、药代动力学特征和治疗的免疫原性。</p>
</div><p>The initial group of programmes from this platform is based on a highly potent and selective PI3K/PIKK inhibitor payload.</p>
<div class="lb-trans"><p>该平台的初始项目组基于一种高效且选择性强的 PI3K/PIKK 抑制剂载体。</p>
</div><p>By attaching this payload to an anti-HER2 antibody, the molecule is said to deliver targeted pathway inhibition directly into tumour cells which express HER2.</p>
<div class="lb-trans"><p>通过将该载体附加到抗 HER2 抗体上，该分子被认为能够将靶向通路抑制直接输送到表达 HER2 的肿瘤细胞中。</p>
</div><p>The company’s ATTC platform is described as a next-generation precision oncology approach, integrating monoclonal antibodies with small-molecule inhibitor payloads for dual mechanisms of action.</p>
<div class="lb-trans"><p>该公司的 ATTC 平台被描述为一种下一代精准肿瘤学方法，结合了单克隆抗体与小分子抑制剂载体，以实现双重作用机制。</p>
</div><p>In March 2025, Hutchmed completed enrolment for its multi-centre Phase II trial of fanregratinib (HMPL-453), a treatment for intrahepatic cholangiocarcinoma (IHCC) patients with fibroblast growth factor receptor 2 fusion or rearrangement.</p>
<div class="lb-trans"><p>在 2025 年 3 月，Hutchmed 完成了招募 其多中心 II 期试验，针对具有成纤维生长因子受体 2 融合或重排的肝内胆管癌（IHCC）患者的 fanregratinib（HMPL-453）治疗。</p>
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和黄医药启动 HMPL-A251 的 I 期临床开发计划