計劃書編號ALE.P02.01
試驗執行中
2025-04-01 - 2028-08-31
Phase I/II
召募中4
一項ALE.P02（Claudin-1 標靶抗體-藥物複合體）單一療法用於選定晚期或轉移性CLDN1+ 鱗狀實質腫瘤成人患者的第I/II 期、開放性、多中心試驗
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/05/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
試驗主持人
協同主持人
實際收案人數
0 召募中
適應症
鱗狀細胞癌
試驗目的
本試驗的目的是評估ALE.P02 單一療法用於選定鱗狀實質腫瘤成人患者的安全性、耐受性、藥物動力學、藥效學、初步抗腫瘤活性，以及確認RP2D。
藥品名稱
輸注液
主成份
ALE.P02
劑型
27C
劑量
60mg
評估指標
• DLT 的發生率
• AE、SAE 的發生率和嚴重程度
• 實驗室數值、生命徵象和心電
圖的臨床上顯著變化
• 耐受性：劑量中斷和劑量強度
• 依據RECIST 1.1 的初步療效參
數：
• ORR 定義為CR 率+ PR 率
• DoR：反應持續時間
註：還將進行CLDN1 和適應症子群組分析
• ORR，定義為依據RECIST 1.1 的
CR 率+ PR 率
• DoR：反應持續時間
註：還將進行CLDN1 和適應症子群組分析
• AE、SAE 的發生率和嚴重程度
• 實驗室數值、生命徵象和心電
圖的臨床上顯著變化
• 耐受性：劑量中斷和劑量強度
• 依據RECIST 1.1 的初步療效參
數：
• ORR 定義為CR 率+ PR 率
• DoR：反應持續時間
註：還將進行CLDN1 和適應症子群組分析
• ORR，定義為依據RECIST 1.1 的
CR 率+ PR 率
• DoR：反應持續時間
註：還將進行CLDN1 和適應症子群組分析
主要納入條件
• Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
• Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
• Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
• Have provided tissue for CLDN1 analysis in a central laboratory.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
• Demonstrate adequate bone marrow and organ function.
• Patients must have recovered from all toxicities led by prior treatment.
Have measurable disease based on RECIST 1.1 as determined by the site.
• Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
• Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
• Have provided tissue for CLDN1 analysis in a central laboratory.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
• Demonstrate adequate bone marrow and organ function.
• Patients must have recovered from all toxicities led by prior treatment.
Have measurable disease based on RECIST 1.1 as determined by the site.
主要排除條件
• Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
• Has received antineoplastic therapies prior to study intervention within specified time frame.
• Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
• Patients with uncontrolled diabetes.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
• Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
• Has received antineoplastic therapies prior to study intervention within specified time frame.
• Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
• Patients with uncontrolled diabetes.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
• Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
試驗計畫預計收納受試者人數
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台灣人數
40 人
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全球人數
170 人
