A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced… (NCT07143604) | Clinical Trial Compass
Active — 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
Russia33 participantsStarted 2025-08-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.