NCT07143604Active, not recruitingPhase 2
A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2
A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 20 Aug 2025
- Start date
- 29 Aug 2025
- Primary completion date
- 14 Aug 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07143604
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 33
- From 29 Aug 2025 to the primary completion date, 14 Aug 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy.
Other illness
- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- History of thromboembolic events.
Other
- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +.
- CNS metastases or CNS pathology.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Kuzmolovskiy | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Volgograd | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.