計劃書編號D9800C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06219941
試驗執行中
2023-11-01 - 2027-12-31
Phase II
召募中4
ICD-10C16.0
賁門部惡性腫瘤
ICD-10C7A.092
胃惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9151.0
胃賁門部惡性腫瘤
一項第二期、開放性、多中心試驗，評估 AZD0901 作為單一療法和併用抗癌藥物使用於表現 Claudin 18.2 之晚期實體腫瘤受試者的安全性、耐受性、療效、藥物動力學及免疫原性 (CLARITY-PanTumour01)
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試驗申請者
臺灣阿斯特捷利康股份有限公司
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試驗委託 / 贊助單位名稱
臺灣阿斯特捷利康股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
適應症
晚期實體腫瘤患者（包含胃癌/胃食道交界處癌及胰臟癌）
試驗目的
研究 AZD0901 單一療法或併用抗癌藥物使用於表現 CLDN18.2 的晚期或轉移性實體腫瘤受試者之安全性和耐受性。
評估 AZD0901 單一療法或併用抗癌藥物使用於表現 CLDN18.2 的晚期或轉移性實體腫瘤受試者之初步抗腫瘤活性（以客觀反應率 [ORR] 評估）。
藥品名稱
凍晶注射劑
主成份
AZD0901
劑型
Lyophiliszed Injection
劑量
50mg (10mg/ml)
評估指標
•研究 AZD0901 單一療法或併用抗癌藥物使用於表現 CLDN18.2 的晚期或轉移性實體腫瘤受試者之安全性和耐受性。
•評估 AZD0901 單一療法或併用抗癌藥物使用於表現 CLDN18.2 的晚期或轉移性實體腫瘤受試者之初步抗腫瘤活性（以客觀反應率 [ORR] 評估）。
•評估 AZD0901 單一療法或併用抗癌藥物使用於表現 CLDN18.2 的晚期或轉移性實體腫瘤受試者之初步抗腫瘤活性（以客觀反應率 [ORR] 評估）。
主要納入條件
Master Inclusion Criteria applicable to both sub studies:
Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Participants who are CLDN18.2 positive.
Must have at least one measurable lesion according to RECIST v1.1.
ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
Predicted life expectancy of ≥ 12 weeks.
Adequate organ and bone marrow function as defined by protocol.
Body weight > 35 kg.
Participants are willing to comply with contraception requirements.
Sub study 1 Specific Inclusion criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Advanced or metastatic GC/GEJC.
Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Sub study 2 Specific Inclusion criteria:
Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
Availability of an archival sample or a fresh tumour biopsy taken at screening.
No prior treatments for unresectable or metastatic disease.
Master Exclusion Criteria applicable to both sub studies:
Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
Participants with clinically significant ascites that require drainage.
A history of drug-induced non-infectious ILD/pneumonitis.
Central nervous system metastases or CNS pathology.
Peripheral neuropathy ≥ Grade 2 at screening.
History of another primary malignancy.
Prior exposure to any MMAE-based ADC.
Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Participants who are CLDN18.2 positive.
Must have at least one measurable lesion according to RECIST v1.1.
ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
Predicted life expectancy of ≥ 12 weeks.
Adequate organ and bone marrow function as defined by protocol.
Body weight > 35 kg.
Participants are willing to comply with contraception requirements.
Sub study 1 Specific Inclusion criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
Advanced or metastatic GC/GEJC.
Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
Sub study 2 Specific Inclusion criteria:
Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
Availability of an archival sample or a fresh tumour biopsy taken at screening.
No prior treatments for unresectable or metastatic disease.
Master Exclusion Criteria applicable to both sub studies:
Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
Participants with clinically significant ascites that require drainage.
A history of drug-induced non-infectious ILD/pneumonitis.
Central nervous system metastases or CNS pathology.
Peripheral neuropathy ≥ Grade 2 at screening.
History of another primary malignancy.
Prior exposure to any MMAE-based ADC.
Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
主要排除條件
Sub study 1 Specific Exclusion criteria:
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
The use of concomitant medications known to prolong the QT/QTc interval.
Sub study 2 Specific Exclusion criteria:
Known DPD enzyme deficiency based on local testing where testing is SoC.
Use of strong inhibitor or inducer of UGT1A1.
Use of strong inhibitors or inducers of CYP3A4.
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
The use of concomitant medications known to prolong the QT/QTc interval.
Sub study 2 Specific Exclusion criteria:
Known DPD enzyme deficiency based on local testing where testing is SoC.
Use of strong inhibitor or inducer of UGT1A1.
Use of strong inhibitors or inducers of CYP3A4.
試驗計畫預計收納受試者人數
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台灣人數
35 人
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全球人數
370 人
