Clinical Trials List
Protocol NumberD9803C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07431281
Active
2025-11-01 - 2031-12-31
Phase III
Not yet recruiting1
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9151.0
Malignant neoplasm of cardia of stomach
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/13
Investigators and Locations
Co-Principal Investigator
- Chien-An Liu 無
- 邱乃祈 無
- 林泰祺 無
- 姜乃榕 無
- Yun-Cheng Hsieh 無
- 張晉瑜 無
- Hung-Yuan Yu 無
- Yi-Ping Hung 無
- San-Chi Chen 無
- 唐振育 無
Co-Principal Investigator
- Chang-Fang Chiu 無
- Chen-Yuan Lin 無
- 王秀慈 無
- Chi-Ching Chen 無
- 陳珈妤 無
Co-Principal Investigator
- Jeng-Shiun Du 無
- Yi-Hsun Chen 無
- 王閔宏 無
- 許瑞峰 無
- Li-Tzong Chen 無
- Wang Yao-Kuang 無
- Tsung-Jang Yeh 無
Co-Principal Investigator
- 梁逸歆 無
- 李佳真 無
- 郭弘揚 無
- 陳國興 無
- 張端瑩 無
- 林宗哲 無
- 陳柏邑 無
- Ying-Chun Shen 無
- YU-YUN SHAO 無
- TSUNG-HAO LIU 無
- Ann-Lii Cheng 無
- 呂理駿 無
- SUNG-HSIN KUO 無
- 莊建淮 無
- Chih-Hung Hsu 無
- 黃柏翔 無
- 陳敬左 無
- TA-CHEN HUANG 無
- Ta-Ching Chen 無
Co-Principal Investigator
- Cheng-Lun Lai 無
- Kuan-Der Lee 無
- ZHENG-WEI ZHOU 無
- HSIN-CHEN LIN 無
- YU-HSUAN SHIH 無
- 曾貫宇 無
- 楊陽生 無
- 吳承翰 無
Co-Principal Investigator
- Chan-Keng Yang 無
- 余紹銘 無
- Hung-Chih Hsu 無
- Yung-Chia Kao 無
- 陳宏吉 無
- 黃文冠 無
- Po-Jung Su 無
- Wen-Chi Shen 無
- Ming-Mo Hou 無
- Wen-Chi Chou 無
Principal Investigator
Yan-Shen Shan
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Gastroesophageal Junction Adenocarcinoma
Objectives
評估sonesitatug vedotin合併capecitabine加上或不加上rilvegostomig用於1L CLDN18.2陽性、HER2陰性胃、胃食道交接處和食道腺癌的療效和安全性。
Test Drug
凍晶乾燥注射劑
注射劑
注射劑
Active Ingredient
Sonesitatug vedotin (AZD0901)
Rilvegostomig (AZD2936)
Rilvegostomig (AZD2936)
Dosage Form
245
270
270
Dosage
50 mg/vial
750 mg/vial
750 mg/vial
Endpoints
第 1 群組：透過評估無惡化存活期 (PFS)，證明 sonesitatug vedotin + rilvegostomig + capecitabine 相較於標準照護 (SoC) 的優越性。
第 2 群組：透過評估 PFS，證明 sonesitatug vedotin + capecitabine 相較於 SoC 的優越性。
第 2 群組：透過評估 PFS，證明 sonesitatug vedotin + capecitabine 相較於 SoC 的優越性。
Inclution Criteria
Inclusion Criteria:
Capable of giving signed informed consent
Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
ECOG performance status of 0 or 1 with no deterioration to > 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
Minimum life expectancy of ≥ 12 weeks.
At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
Adequate organ and bone marrow function as specified in the protocol
Body weight ≥ 35 kg.
Sex and contraceptive requirements
Capable of giving signed informed consent
Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
ECOG performance status of 0 or 1 with no deterioration to > 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
Minimum life expectancy of ≥ 12 weeks.
At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
Adequate organ and bone marrow function as specified in the protocol
Body weight ≥ 35 kg.
Sex and contraceptive requirements
Exclusion Criteria
Exclusion Criteria:
Known HER2-positive status
Significant or unstable gastric bleeding and/or untreated gastric ulcers.
Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
CNS pathology
Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cardiac abnormalities as outlined in the protocol
Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
Known partial or total DPD enzyme deficiency
Known HER2-positive status
Significant or unstable gastric bleeding and/or untreated gastric ulcers.
Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
CNS pathology
Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cardiac abnormalities as outlined in the protocol
Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
Known partial or total DPD enzyme deficiency
The Estimated Number of Participants
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Taiwan
95 participants
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Global
2130 participants
