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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-29

Study Completion Date

2027-09-28

Brief Summary

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The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

Detailed Description

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This is a Phase II, single arm, open label, multicentre study, assessing the efficacy and safety of AZD0901 in participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. The results of the study will provide clinical data on efficacy and safety of an innovation drug in Russian Federation.

Conditions

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Gastric Cancer Gastroesophageal Junction Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will receive AZD0901 IV, Q3W
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open-label

Study Groups

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AZD0901

Participants will receive AZD0901 IV, Q3W

Group Type EXPERIMENTAL

AZD0901

Intervention Type DRUG

Participants will receive AZD0901 IV, Q3W

Interventions

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AZD0901

Participants will receive AZD0901 IV, Q3W

Intervention Type DRUG

Other Intervention Names

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Sonesitatug Vedotin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.
* 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

* Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Chelyabinsk, , Russia

Site Status RECRUITING

Research Site

Krasnoyarsk, , Russia

Site Status NOT_YET_RECRUITING

Research Site

Kuzmolovskiy, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Moscow, , Russia

Site Status RECRUITING

Research Site

Nizhny Novgorod, , Russia

Site Status RECRUITING

Research Site

Novosibirsk, , Russia

Site Status NOT_YET_RECRUITING

Research Site

Saint Petersburg, , Russia

Site Status RECRUITING

Research Site

Saint Petersburg, , Russia

Site Status RECRUITING

Research Site

Volgograd, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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AZ-RU-00007

Identifier Type: -

Identifier Source: org_study_id

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