<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>該 I/IIa 期研究將評估 HMPL-A251 作為單一藥物在無法切除的晚期或轉移性 HER2 表達固體腫瘤成人患者中的療效。來源：PeopleImages / Shutterstock.com。</p>
<p>Hutchmed 已啓動其全球 I 期臨牀開發計劃，針對首個類磷脂酰肌醇 3 激酶（PI3K）/類磷脂酰肌醇 3 激酶相關蛋白激酶（PIKK）- 人表皮生長因子受體 2（HER2）抗體靶向治療結合物（ATTC）HMPL-A251。</p>
<p>該研究的臨牀試驗地點位於中國和美國。最近，首位患者在中國接受了劑量治療。</p>
<p>該首個人體 I/IIa 期多中心開放標籤臨牀研究將評估 HMPL-A251 作為單一藥物在無法切除的晚期或轉移性 HER2 表達固體腫瘤成人患者中的療效。</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>該臨牀研究分為兩個部分：I 期劑量遞增階段和 IIa 期劑量擴展與優化階段。</p>
<p>其主要目標是評估 HMPL-A251 的耐受性和安全性，並在 I 期期間確定最大耐受劑量（MTD）和/或推薦擴展劑量（RDE）。</p>
<p>在 IIa 期部分，研究將進一步評估初步療效、安全性在 RDE 下，並確定 II 期（RP2D）或 III 期（RP3D）的推薦劑量。</p>
<p>次要結果指標包括評估初步抗腫瘤活性、藥代動力學特徵和治療的免疫原性。</p>
<p>該平台的初始項目組基於一種高效且選擇性強的 PI3K/PIKK 抑制劑載體。</p>
<p>通過將該載體附加到抗 HER2 抗體上，該分子被認為能夠將靶向通路抑制直接輸送到表達 HER2 的腫瘤細胞中。</p>
<p>該公司的 ATTC 平台被描述為一種下一代精準腫瘤學方法，結合了單克隆抗體與小分子抑制劑載體，以實現雙重作用機制。</p>
<p>在 2025 年 3 月，Hutchmed 完成了招募 其多中心 II 期試驗，針對具有成纖維生長因子受體 2 融合或重排的肝內膽管癌（IHCC）患者的 fanregratinib（HMPL-453）治療。</p>
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和黃醫藥

<p>和黃醫藥已啓動 HMPL-A251 的全球 I 期臨牀開發項目，這是一種首創的 PI3K/PIKK-HER2 抗體靶向治療結合物。該研究將在中國和美國進行，旨在評估該療法在晚期 HER2 表達腫瘤成人患者中的效果。該試驗包括 I 期劑量遞增和 IIa 期劑量擴展階段，重點關注安全性、耐受性和療效。ATTC 平台將單克隆抗體與小分子抑制劑結合，以實現精準腫瘤治療</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>該 I/IIa 期研究將評估 HMPL-A251 作為單一藥物在無法切除的晚期或轉移性 HER2 表達固體腫瘤成人患者中的療效。來源：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 已啓動其全球 I 期臨牀開發計劃，針對首個類磷脂酰肌醇 3 激酶（PI3K）/類磷脂酰肌醇 3 激酶相關蛋白激酶（PIKK）- 人表皮生長因子受體 2（HER2）抗體靶向治療結合物（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>該研究的臨牀試驗地點位於中國和美國。最近，首位患者在中國接受了劑量治療。</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>該首個人體 I/IIa 期多中心開放標籤臨牀研究將評估 HMPL-A251 作為單一藥物在無法切除的晚期或轉移性 HER2 表達固體腫瘤成人患者中的療效。</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>Explore a selection of report samples we have handpicked for you. Get a preview of the insights inside. Download your free copy today.</p>
<div class="lb-trans"><p>探索我們為您精心挑選的一系列報告樣本。獲取內部見解的預覽。今天就下載您的免費副本。</p>
</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>該臨牀研究分為兩個部分：I 期劑量遞增階段和 IIa 期劑量擴展與優化階段。</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>其主要目標是評估 HMPL-A251 的耐受性和安全性，並在 I 期期間確定最大耐受劑量（MTD）和/或推薦擴展劑量（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，研究將進一步評估初步療效、安全性在 RDE 下，並確定 II 期（RP2D）或 III 期（RP3D）的推薦劑量。</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>次要結果指標包括評估初步抗腫瘤活性、藥代動力學特徵和治療的免疫原性。</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>該平台的初始項目組基於一種高效且選擇性強的 PI3K/PIKK 抑制劑載體。</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>通過將該載體附加到抗 HER2 抗體上，該分子被認為能夠將靶向通路抑制直接輸送到表達 HER2 的腫瘤細胞中。</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>該公司的 ATTC 平台被描述為一種下一代精準腫瘤學方法，結合了單克隆抗體與小分子抑制劑載體，以實現雙重作用機制。</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 期試驗，針對具有成纖維生長因子受體 2 融合或重排的肝內膽管癌（IHCC）患者的 fanregratinib（HMPL-453）治療。</p>
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和黃醫藥啓動 HMPL-A251 的 I 期臨牀開發計劃