A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
NCT ID: NCT07069712
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-07-17
2028-09-06
Brief Summary
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Detailed Description
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Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sub-study 1: AZD0901 plus rilvegostomig and 5-FU or capecitabine
Participants will receive AZD0901 plus rilvegostomig and 5-FU or capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy (as optional).
AZD0901
AZD0901 will be administered as an IV infusion.
Rilvegostomig
Rilvegostomig will be administered as an IV infusion.
Capecitabine
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
Sub-study 2: T-DXd plus rilvegostomig and 5-FU or capecitabine
Participants will receive T-DXd plus rilvegostomig and 5-FU or capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy (as optional).
Rilvegostomig
Rilvegostomig will be administered as an IV infusion.
Trastuzumab Deruxtecan (T-DXd)
T-DXd will be administered as an IV infusion.
Capecitabine
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
Sub-study 3: Rilvegostomig plus FLOT chemotherapy
Participants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant combination therapy (post-surgery period) and later will receive Rilvegostomig as adjuvant monotherapy (as optional).
Rilvegostomig
Rilvegostomig will be administered as an IV infusion.
FLOT Chemotherapy
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Interventions
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AZD0901
AZD0901 will be administered as an IV infusion.
Rilvegostomig
Rilvegostomig will be administered as an IV infusion.
Trastuzumab Deruxtecan (T-DXd)
T-DXd will be administered as an IV infusion.
Capecitabine
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
FLOT Chemotherapy
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ and bone marrow function
* Body weight \> 35 kg
Exclusion Criteria
* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
* Central nervous system (CNS) pathology
* Uncontrolled infections
* Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
* History of another primary malignancy
* Participants with any known or suspicious distant metastasis
* Uncontrolled hepatitis B and/or chronic or active hepatitis B
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Newark, Delaware, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Fairway, Kansas, United States
Research Site
North Shores, Michigan, United States
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New York, New York, United States
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New York, New York, United States
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Pittsburgh, Pennsylvania, United States
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Changchun, , China
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Changzhi, , China
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Chengdu, , China
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Chengdu, , China
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Fuzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Kunming, , China
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Qingdao, , China
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Shanghai, , China
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Shijiazhuang, , China
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Pisa, , Italy
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Rozzano, , Italy
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Udine, , Italy
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Vicenza, , Italy
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Chūōku, , Japan
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Fukuoka, , Japan
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Hidaka-shi, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kōtoku, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Suita-shi, , Japan
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Bialystok, , Poland
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Warsaw, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Elche, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Ourense, , Spain
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Oviedo, , Spain
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Santander, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Adapazarı, , Turkey (Türkiye)
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Erzurum, , Turkey (Türkiye)
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Fatih-Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Bristol, , United Kingdom
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Dundee, , United Kingdom
Research Site
Headington, , United Kingdom
Research Site
Norwich, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-516909-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
D9804C00001
Identifier Type: -
Identifier Source: org_study_id