A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2

NCT07143604 | Active Not Recruiting Phase 2

• 1 other identifier: AZ-RU-00007
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Keywords

Gastric cancer; Gastroesophageal junction cancer; Claudin 18.2; AZD0901

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator per RECIST 1.1 to all dosed participants

  At month 6 after date of first dose

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months

• Overall Survival (OS)

  From the date of assignment until the date of death from any cause, assessed up to 30 months

• Disease control rate (DCR) at 12 weeks

  At 12 weeks after date of first dose

• Duration of Response (DoR)

  From the date of first documented confirmed response until date of documented progression, assessed up to 30 months

• Time to Response (TTR)

  From the date of first dose to the first documented objective tumor response, assessed up to 30 months

Study Arms (1)

AZD0901

EXPERIMENTAL

Participants will receive AZD0901 IV, Q3W

Drug: AZD0901

Interventions

AZD0901 DRUG

Participants will receive AZD0901 IV, Q3W

Also known as: Sonesitatug Vedotin

AZD0901

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Chelyabinsk, 454092, Russia

Location

Research Site

Krasnoyarsk, 660133, Russia

Location

Research Site

Kuzmolovskiy, 188663, Russia

Location

Research Site

Moscow, 111123, Russia

Location

Research Site

Moscow, 115478, Russia

Location

Research Site

Moscow, 115533, Russia

Location

Research Site

Moscow, 125284, Russia

Location

Research Site

Moscow, 142770, Russia

Location

Research Site

Moscow, 143423, Russia

Location

Research Site

Nizhny Novgorod, 603126, Russia

Location

Research Site

Saint Petersburg, 197022, Russia

Location

Research Site

Saint Petersburg, 197758, Russia

Location

Research Site

Volgograd, Unk, Russia

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive AZD0901 IV, Q3W

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

RU (13)