At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Rilvegostomig (drug), Volrustomig (drug), FOLFOX (drug), XELOX (drug)
- How long the study runs
- Study runs about 76 months (dates as stated)
- About the drug or intervention
- Rilvegostomig — drug: an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion · Volrustomig — drug: an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion · FOLFOX — drug: 5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available) · XELOX — drug: capecitabine and oxaliplatin · AZD0901 — drug: an anti Claudin18.2 ADC; IV infusion · 5-Fluorouracil — drug: 5-FU, IV infusion · Capecitabine — drug: Oral take
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial, run by AstraZeneca, is for adults with advanced stomach cancer (gastric cancer) or cancer where the stomach meets the food pipe (gastroesophageal junction), that cannot be removed by surgery or has spread. It is testing new combinations of treatments. Not stated — ask the trial team for details of the treatments being tested.
Who can take part
- Aged 18 or over
- Body weight over 35 kg
- Not yet treated for stomach or gastroesophageal junction cancer that cannot be removed by surgery or has spread
- Have cancer that can be measured on scans
- Able to carry out light activity (performance status 0 or 1)
- Expected to live at least 12 weeks
- Healthy enough organs and bone marrow
- Have had a laboratory test of their tumour to check for a marker called Claudin18.2, either from a stored sample taken in the past 24 months or a new biopsy
Who may not be able to
- Cancer that is HER2-positive (a different marker) or unclear HER2 status
- Untreated or worsening cancer spread to the brain or spinal cord, or certain nerve coverings
- Fluid build-up in the tummy (ascites) that cannot be controlled
- Active infections such as tuberculosis, HIV, or hepatitis B or C
- Other serious uncontrolled illness
- Autoimmune or inflammatory conditions needing steroid or immunosuppressive treatment
- History of another type of cancer
- Previous treatment with immunotherapy drugs
- Previous treatment targeting Claudin18.2 or with a drug called MMAE (when certain substudies are open)
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 163
- Started
- 2023-01-16
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for gastric cancer
- • Phase2 - 163 participants
- • This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with gastric cancer
Where?
- • Edinburgh - Research Site
- • Leeds - Research Site
- • London - Research Site
- • Oxford - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
More detail
Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓18 years or older at the time of signing the ICF.
- ✓Body weight \> 35 kg.
- ✓Previously untreated for unresectable or that has spread gastric or gastroesophageal junction adenocarcinoma.
- ✓Has measurable target disease assessed by the Investigator based on (standard scan measurements).
- ✓ECOG PS zero or one.
Who cannot take part
- ✗Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate...
- ✗Untreated or progressive CNS that has spread disease, any leptomeningeal disease, or cord compression.
- ✗Participants with ascites which cannot be controlled with appropriate interventions.
- ✗Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.
- ✗Uncontrolled intercurrent illness.
See the full criteria
Where Is This Study? (4 UK sites)
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London EC1M 6BQ, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT