A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2
NCT ID: NCT07143604
Last Updated: 2026-01-20
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
33 participants
INTERVENTIONAL
2025-08-29
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AZD0901
Participants will receive AZD0901 IV, Q3W
AZD0901
Participants will receive AZD0901 IV, Q3W
Interventions
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AZD0901
Participants will receive AZD0901 IV, Q3W
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
* Must have at least one measurable lesion assessed by the Investigator based on RECIST 1.1.
* ECOG performance status of 0 or 1.
* Minimum life expectancy of ≥12 weeks.
* Adequate organ and bone marrow function.
* Minimum body weight of 40 kg.
* Sex and Contraceptive Requirements.
Exclusion Criteria
* Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
* CNS metastases or CNS pathology.
* Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
* Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy.
* History of thromboembolic events.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Chelyabinsk, , Russia
Research Site
Krasnoyarsk, , Russia
Research Site
Kuzmolovskiy, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Volgograd, , Russia
Countries
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Central Contacts
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Other Identifiers
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AZ-RU-00007
Identifier Type: -
Identifier Source: org_study_id
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