Status:
RECRUITING
A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2
Lead Sponsor:
AstraZeneca
Conditions:
Gastric Cancer
Gastroesophageal Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2027
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT07143604
Start Date
August 29 2025
End Date
September 28 2027
Last Update
December 15 2025
Active Locations (14)
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1
Research Site
Chelyabinsk, Russia, 454092
2
Research Site
Krasnoyarsk, Russia, 660133
3
Research Site
Kuzmolovskiy, Russia, 188663
4
Research Site
Moscow, Russia, 111123