Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT05702229
Last Updated: 2025-11-17
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
240 participants
INTERVENTIONAL
2023-01-16
2027-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Substudy 1
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
FOLFOX
5-fluorouracil 400 mg/m\^2 IV, oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2 (or levoleucovorin 200 mg/m\^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m\^2 IV 24 h day 1-2
XELOX
capecitabine 1000 mg/m\^2 BID, days 1 to 14, oxaliplatin 130 mg/m\^2, day 1
Substudy 2
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
FOLFOX
5-fluorouracil 400 mg/m\^2 IV, oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2 (or levoleucovorin 200 mg/m\^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m\^2 IV 24 h day 1-2
XELOX
capecitabine 1000 mg/m\^2 BID, days 1 to 14, oxaliplatin 130 mg/m\^2, day 1
Substudy 3
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
AZD0901
an anti Claudin18.2 ADC; IV infusion
5-Fluorouracil
5-FU, IV infusion, Q3W
Capecitabine
Oral take, Q3W
Substudy 4
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
AZD0901
an anti Claudin18.2 ADC; IV infusion
5-Fluorouracil
5-FU, IV infusion, Q3W
Capecitabine
Oral take, Q3W
Substudy 5
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
FOLFOX
5-fluorouracil 400 mg/m\^2 IV, oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2 (or levoleucovorin 200 mg/m\^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m\^2 IV 24 h day 1-2
XELOX
capecitabine 1000 mg/m\^2 BID, days 1 to 14, oxaliplatin 130 mg/m\^2, day 1
AZD7789
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
Substudy 6
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
AZD7789
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
AZD0901
an anti Claudin18.2 ADC; IV infusion
5-Fluorouracil
5-FU, IV infusion, Q3W
Capecitabine
Oral take, Q3W
Interventions
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Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
FOLFOX
5-fluorouracil 400 mg/m\^2 IV, oxaliplatin 85 mg/m\^2, leucovorin 400 mg/m\^2 (or levoleucovorin 200 mg/m\^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m\^2 IV 24 h day 1-2
XELOX
capecitabine 1000 mg/m\^2 BID, days 1 to 14, oxaliplatin 130 mg/m\^2, day 1
AZD7789
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
AZD0901
an anti Claudin18.2 ADC; IV infusion
5-Fluorouracil
5-FU, IV infusion, Q3W
Capecitabine
Oral take, Q3W
Eligibility Criteria
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Inclusion Criteria
* Body weight \> 35 kg.
* Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
* Has measurable target disease assessed by the Investigator based on RECIST 1.1.
* ECOG PS zero or one.
* Life expectancy of at least 12 weeks.
* Adequate organ and bone marrow function.
* Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.
Exclusion Criteria
* Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
* Participants with ascites which cannot be controlled with appropriate interventions.
* Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
* Uncontrolled intercurrent illness.
* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
* History of another primary malignancy.
* Previous treatment with an immune-oncology agent.
* Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Shirley, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Beijing, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Hefei, , China
Research Site
Kunming, , China
Research Site
Wuhan, , China
Research Site
Yinchuan, , China
Research Site
Zhengzhou, , China
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Elche(Alicante), , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Santander, , Spain
Research Site
Hsinchu, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Edinburgh, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2022-002840-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7986C00001
Identifier Type: -
Identifier Source: org_study_id
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