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治験 NCT07431281（対象：胃がん、胃食道接合部腺癌、食道癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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アストラゼネカSonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 第III相・フェーズ3 2,130
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07431281 は 胃がん、胃食道接合部腺癌、食道癌 に関する 治療 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2026年2月3日 から開始しています。2,130 名の参加者 の募集が計画されています。この試験は アストラゼネカ によって主導され、2031年10月27日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月24日 です。
概要
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
詳細説明
The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER...もっと見る
公式タイトル
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)
疾患名
胃がん胃食道接合部腺癌食道癌その他の研究識別子
- D9803C00001
- 2024-519787-40-00 (登録識別子) (Clinical Trials Information System (CTIS))
NCT番号
開始日
2026-02-03
最終更新日
2026-02-24
終了予定日
2031-10-27
目標参加者数
2,130
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
募集中
キーワード
Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,
Advanced Gastric Adenocarcinoma,
Advanced Esophageal Adenocarcinoma,
Metastatic Gastric Adenocarcinoma,
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,
Metastatic Esophageal Adenocarcinoma,
Claudin 18.2,
PD-L1,
Human epidermal growth factor receptor 2 (HER2) Negative
Advanced Gastric Adenocarcinoma,
Advanced Esophageal Adenocarcinoma,
Metastatic Gastric Adenocarcinoma,
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,
Metastatic Esophageal Adenocarcinoma,
Claudin 18.2,
PD-L1,
Human epidermal growth factor receptor 2 (HER2) Negative
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm A Sonesitatug vedotin + Rilvegostomig + Capecitabine | Sonesitatug vedotin Intravenous Rilvegostomig Intravenous Capecitabine Oral |
実験的Arm B Sonesitatug vedotin + Nivolumab + Capecitabine | Sonesitatug vedotin Intravenous Nivolumab Intravenous Capecitabine Oral |
実薬対照薬Arm C Nivolumab + CAPOX OR Nivolumab + FOLFOX
* nivolumab, capecitabine, oxaliplatin
* nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin | Nivolumab Intravenous Capecitabine Oral 5-Fluorouracil Intravenous Oxaliplatin Intravenous Leucovorin Intravenous |
実験的Arm D Sonesitatug vedotin + Capecitabine | Sonesitatug vedotin Intravenous Capecitabine Oral |
実薬対照薬Arm E Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX:
* zolbetuximab, capecitabine, oxaliplatin
* zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin
CAPOX or FOLFOX:
* oxaliplatin, capecitabine,
* 5-Fluorouracil, leucovorin, oxaliplatin | Capecitabine Oral 5-Fluorouracil Intravenous Oxaliplatin Intravenous Zolbetuximab Intravenous Leucovorin Intravenous |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Progression Free Survival (PFS) (Cohort 1 and Cohort 2) | PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first. | Up to approximately 5 years |
Overall Survival (OS) (Cohort 1) | OS is defined as the time from randomisation until the date of death due to any cause. | Up to approximately 5 years |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Overall Survival (OS) (Cohort 2) | OS is defined as the time from randomisation until the date of death due to any cause. | Up to approximately 5 years |
Overall Survival (OS) (Cohort 1) | OS is defined as time from randomisation until date of death due to any cause. Arm B versus C. | Up to approximately 5 years |
Progression Free Survival (PFS) (Cohort 1) | PFS is defined as time from randomisation until progression per RECIST 1.1 or death due to any cause, whichever occurs first. Arms B versus C. | Up to approximately 5 years |
Objective Response Rate (ORR) (Cohort 1 and Cohort 2) | ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, per RECIST 1.1. | Up to approximately 5 years |
Duration of Response (DoR) (Cohort 1 and Cohort 2) | DoR (per RECIST 1.1) is derived for confirmed objective responses (CR or PR) only and is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression (ie, date of PFS event - date of first response + 1). | Up to approximately 5 years |
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) | Pharmacokinetic parameters of sonesitatug vedotin (peak plasma concentration (Cmax)) | Up to approximately 5 years |
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) | Pharmacokinetic parameters of sonesitatug vedotin (trough plasma concentration (Cmin)) | Up to approximately 5 years |
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2) | Presence of ADAs for sonesitatug vedotin in serum (confirmatory results: positive or negative, titres). | Up to approximately 5 years |
Pharmacokinetics of rilvegostomig (Cohort 1) | Pharmacokinetic parameters of rilvegostomig (peak plasma concentration (Cmax)) | Up to approximately 5 years |
Pharmacokinetics of rilvegostomig (Cohort 1) | Pharmacokinetic parameters of rilvegostomig (trough plasma concentration (Cmin)) | Up to approximately 5 years |
Immunogenicity of rilvegostomig (Cohort 1) | Presence of ADAs for rilvegostomig in serum (confirmatory results: positive or negative, titres). | Up to approximately 5 years |
Safety and tolerability (Cohort 1 and Cohort 2) | Safety and tolerability as evaluated in terms of incidence of AEs and SAEs | Up to approximately 5 years |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
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
- 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
アストラゼネカ試験中央連絡先
連絡先: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
230 20カ国の場所
Research Site, Hirakata-shi, 573-1191, Japan
募集準備中
Research Site, Kashiwa, 277-8577, Japan
募集準備中
Research Site, Kitaadachi-gun, 362-0806, Japan
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Research Site, Kōtoku, 135-8550, Japan
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Research Site, Niigata, 951-8566, Japan
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Research Site, Phoenix, Arizona, 85054, United States
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California
Research Site, Duarte, California, 91010, United States
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Research Site, Lone Tree, Colorado, 80124, United States
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Research Site, New Haven, Connecticut, 06510, United States
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Delaware
Research Site, Newark, Delaware, 19713, United States
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District of Columbia
Research Site, Washington D.C., District of Columbia, 20007, United States
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Florida
Research Site, Fort Myers, Florida, 33901, United States
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Research Site, Jacksonville, Florida, 32224, United States
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Research Site, St. Petersburg, Florida, 33705, United States
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Research Site, West Palm Beach, Florida, 33401, United States
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Research Site, Atlanta, Georgia, 30309, United States
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Research Site, Atlanta, Georgia, 30322, United States
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Research Site, Atlanta, Georgia, 30342, United States
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Illinois
Research Site, Chicago, Illinois, 60637, United States
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Research Site, Niles, Illinois, 60714, United States
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Kentucky
Research Site, Lexington, Kentucky, 40536, United States
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Research Site, Louisville, Kentucky, 40207, United States
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Massachusetts
Research Site, Boston, Massachusetts, 02114, United States
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Michigan
Research Site, Grand Rapids, Michigan, 49503, United States
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Research Site, Burnsville, Minnesota, 55337, United States
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Research Site, Rochester, Minnesota, 55905, United States
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Research Site, Kansas City, Missouri, 64132, United States
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Research Site, St Louis, Missouri, 63110, United States
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Research Site, East Brunswick, New Jersey, 08816, United States
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Research Site, Hackensack, New Jersey, 07601, United States
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Research Site, Summit, New Jersey, 07901, United States
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New York
Research Site, New York, New York, 10029, United States
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Research Site, New York, New York, 10032, United States
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Research Site, New York, New York, 10065, United States
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Research Site, The Bronx, New York, 10461, United States
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Research Site, The Bronx, New York, 10468, United States
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Research Site, White Plains, New York, 10601, United States
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Research Site, Winston-Salem, North Carolina, 27103, United States
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Research Site, Cleveland, Ohio, 44195, United States
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Research Site, Columbus, Ohio, 43221, United States
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Research Site, Portland, Oregon, 97213, United States
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Research Site, Portland, Oregon, 97239, United States
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Pennsylvania
Research Site, Hershey, Pennsylvania, 17033, United States
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Research Site, Philadelphia, Pennsylvania, 19104, United States
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Research Site, Pittsburgh, Pennsylvania, 15232, United States
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Research Site, Pittsburgh, Pennsylvania, 15240, United States
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Research Site, Wilkes-Barre, Pennsylvania, 18711, United States
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South Dakota
Research Site, Sioux Falls, South Dakota, 57105, United States
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Research Site, Memphis, Tennessee, 38104, United States
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Research Site, Nashville, Tennessee, 37203, United States
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Texas
Research Site, Dallas, Texas, 75246, United States
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Research Site, Sherman, Texas, 75090, United States
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Research Site, Blacksburg, Virginia, 24060, United States
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Research Site, Fairfax, Virginia, 22031, United States
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Research Site, Falls Church, Virginia, 22042, United States
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Research Site, Seattle, Washington, 98104, United States
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West Virginia
Research Site, Charleston, West Virginia, 25315, United States
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Research Site, Darlinghurst, 2010, Australia
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Research Site, Garran, 2605, Australia
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Research Site, Heidelberg, 3084, Australia
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Research Site, Murdoch, 6150, Australia
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Alberta
Research Site, Edmonton, Alberta, T6G 1Z2, Canada
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British Columbia
Research Site, Abbotsford British Columbia, British Columbia, V2S0C2, Canada
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Research Site, Vancouver, British Columbia, VSZ 4E6, Canada
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Manitoba
Research Site, Winnipeg, Manitoba, R3E 0V9, Canada
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Ontario
Research Site, Brampton, Ontario, L6R 3J7, Canada
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Research Site, Ottawa, Ontario, K1H 8L6, Canada
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Research Site, Toronto, Ontario, M4N 3M5, Canada
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Research Site, Toronto, Ontario, M5G 2M9, Canada
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Research Site, Montreal, Quebec, H3A 1A1, Canada
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Research Site, Beijing, 102200, China
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Research Site, Hefei, 230031, China
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Research Site, Hohhot, 010020, China
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Research Site, Jinan, 2501117, China
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Research Site, Kunming, 650118, China
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Research Site, Linhai, 317000, China
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Research Site, Linyi, 276000, China
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Research Site, Nanchang, 330029, China
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Research Site, Seoul, 03722, South Korea
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Research Site, Seoul, 05505, South Korea
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Research Site, Kaohsiung City, 80756, Taiwan
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Research Site, Kaohsiung City, 83301, Taiwan
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Research Site, Taichung, 40447, Taiwan
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Research Site, Taichung, Taiwan
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Research Site, Tainan, 704, Taiwan
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Research Site, Taipei, 10002, Taiwan
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Research Site, Taipei, 112, Taiwan
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Research Site, Taoyuan District, 333, Taiwan
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Research Site, Bangkok, 10210, Thailand
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Research Site, Bangkok, 10700, Thailand
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Research Site, Dusit, 10300, Thailand
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Research Site, Hat Yai, 90110, Thailand
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Research Site, Khon Kaen, 40002, Thailand
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Research Site, Muang, 22000, Thailand
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Research Site, Muang, 70000, Thailand
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Research Site, Ankara, 06530, Turkey (Türkiye)
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Research Site, Antalya, 07100, Turkey (Türkiye)
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Research Site, Istanbul, 34098, Turkey (Türkiye)
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Research Site, Istanbul, 34854, Turkey (Türkiye)
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Research Site, Medreseboğazı, 01250, Turkey (Türkiye)
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Research Site, Şahinbey, 27310, Turkey (Türkiye)
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Research Site, Cambridge, CB2 0QQ, United Kingdom
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Research Site, Dundee, DD1 9SY, United Kingdom
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Research Site, Leeds, LS9 7TF, United Kingdom
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Research Site, London, EC1A 7BE, United Kingdom
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Research Site, Manchester, M20 4BX, United Kingdom
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Research Site, Oxford, OX3 7LE, United Kingdom
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