Study for AZD4360 in Participants With Advanced Solid Tumours (NCT06921928) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study for AZD4360 in Participants With Advanced Solid Tumours
United States, China, Germany31 participantsStarted 2025-04-29
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Who can participate
Age range
18 Years – 130 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
. Participant must be ≥ 18 at the time of signing the ICF.
. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
. Minimum life expectancy of 12 weeks in the opinion of the Investigator.
Exclusion criteria
. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
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.
1Since this is a Phase 1/2 trial and the main thing being measured is how often people experience serious side effects or have to stop treatment because of them, what does that mean for what is actually known — and not yet known — about whether AZD4360 is safe or effective for my specific cancer?
2This trial is listed as 'active but not recruiting,' which suggests they are no longer enrolling new patients — is there any chance that changes, or are there related studies involving AZD4360 that might still be open to me?
3Given that this study covers several different cancer types including gastric, gastroesophageal junction, biliary tract, and pancreatic ductal adenocarcinoma, does the evidence or rationale for AZD4360 seem stronger for my particular diagnosis, and how does that affect whether this could be worth pursuing?
4Compared to whatever standard treatments are still available to me, what would I be giving up or potentially gaining by being in a dose-escalation study where finding the right safe dose is still the primary goal?
5If I were able to join a trial like this, how would the monitoring for dose-limiting toxicities and serious adverse events actually work in practice — how often would I need to come in, and what happens if I have a bad reaction?
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.
What they're measuring
1
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
Timeframe: Through study completion, up to approximately 2 years