Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
This clinical trial is designed for people with advanced stomach, gastroesophageal junction, or oesophageal cancers that have a specific marker called Claudin18.2. Researchers are investigating new combinations of treatments, including sonesitatug vedotin, with common chemotherapy (capecitabine), and sometimes an additional drug called rilvegostomig. The main goal is to find out if these new combinations are effective in shrinking the cancer or stopping it from growing, and to understand any potential side effects. This is a large, advanced-stage study (Phase 3), meaning these treatments have shown promise in earlier research. It's looking for the best first treatment option for these types of cancers that are Claudin18.2 positive and HER2 negative, aiming to improve outcomes for patients.
At a glance
What is this study about?
This study is looking into new ways to treat advanced stomach cancer, cancer where the gullet joins the stomach (gastroesophageal junction), and cancer of the lower gullet (oesophageal cancer). These are cancers that have spread or cannot be removed by surgery. The focus is specifically on cancers that have a particular feature called 'Claudin18.2 positive'. Your doctor can check for this marker with a special test.
The trial is testing combinations of medicines which include 'sonesitatug vedotin', often with a chemotherapy drug called 'capecitabine'. In some cases, another drug called 'rilvegostomig' might also be included. The aim is to see how well these new drug combinations work together to slow down or shrink the cancer, and to understand if they cause any side effects.
This is a 'Phase 3' study, which means these treatments have already shown some promise in earlier research. Researchers want to compare them to existing treatments to find out if they offer a better option for people whose cancer has the Claudin18.2 marker and is 'HER2 negative' (another feature your doctor can test for). The hope is to find more effective and safer first-line treatments for these types of cancers.
Key takeaways
- This study is for advanced stomach, gastroesophageal junction, or oesophageal cancers.
- It's for people whose cancer has the Claudin18.2 marker and is HER2 negative.
- It's testing new drug combinations of sonesitatug vedotin, capecitabine, and sometimes rilvegostomig.
- The aim is to find effective and safe 'first-line' treatments.
- This is a Phase 3 study, meaning treatments have shown promise in earlier research.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be at least 18 years old and have advanced stomach, gastroesophageal junction, or lower oesophageal cancer that doctors have confirmed cannot be removed by surgery or has spread. A crucial requirement is that your cancer must show a specific marker called 'Claudin18.2 positive' when tested. Your cancer also needs to be 'HER2 negative'.
Your general health would be assessed to make sure you are well enough to take part, including having normal function of your organs and bone marrow. You should also be able to carry out most of your usual daily activities without too much difficulty. There are different groups within the study depending on another marker called 'PD-L1' and whether your doctor thinks an 'immune checkpoint inhibitor' treatment is suitable for you.
However, you wouldn't be able to join if your cancer is already known to be HER2 positive, or if you have certain active or past autoimmune conditions that needed strong medication. Significant untreated stomach bleeding, severe nerve damage, or certain issues with fluid build-up in your body would also prevent you from participating.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have advanced stomach, gastroesophageal junction, or lower gullet cancer?
- Has your doctor confirmed your cancer is 'Claudin18.2 positive' and 'HER2 negative'?
- Are you in generally good health, able to manage most daily activities?
- Do you have adequate organ function (as confirmed by your doctor)?
- Have you *not* had strong treatments for autoimmune conditions recently?
What does participation involve?
If you join this study, you will have regular visits to the clinic for assessments. This will include physical examinations, blood tests, and scans to monitor your cancer and check how you are responding to the treatment. You will receive the study medication as prescribed by the research team. The specific drugs you receive (sonesitatug vedotin, capecitabine, and potentially rilvegostomig) will be determined by which study group you are in.
The research team will closely monitor you for any side effects and your general well-being throughout the treatment period. After you stop receiving the study treatment, there will be follow-up visits or phone calls to continue monitoring your health for a period of time. The total duration of your participation, including the treatment and follow-up, will vary depending on your individual response and the study's protocol, but the team will explain this fully if you are considering joining.
Potential risks and benefits
Locations (269)
- Research SiteVerified postcodePhoenix, United States· Not yet recruiting
- Research SiteVerified postcodeSpringdale, United States· Not yet recruiting
- Research SiteVerified postcodeDuarte, United States· Not yet recruiting
- Research SiteVerified postcodeFullerton, United States· Not yet recruiting
- Research SiteVerified postcodeLa Jolla, United States· Not yet recruiting
- Research SiteVerified postcodeLos Alamitos, United States· Not yet recruiting
- Research SiteVerified postcodeOrange, United States· Not yet recruiting
- Research SiteVerified postcodeWalnut Creek, United States· Not yet recruiting
- Research SiteVerified postcodeDenver, United States· Not yet recruiting
- Research SiteVerified postcodeLone Tree, United States· Not yet recruiting
- Research SiteVerified postcodeNew Haven, United States· Withdrawn
- Research SiteVerified postcodeNewark, United States· Not yet recruiting
Common questions
What is Claudin18.2?
Claudin18.2 is a specific protein found on the surface of some cancer cells, particularly in certain stomach and oesophageal cancers. This study is for people whose cancer has this marker.
What does 'HER2 negative' mean?
HER2 is another protein that can be found on cancer cells. 'HER2 negative' means your cancer cells don't have high levels of this protein, which helps doctors decide the best treatment approach.
What are 'Phase 3' studies?
Phase 3 studies are large-scale trials that compare a new treatment with existing standard treatments to see if the new one is better or has fewer side effects. They are a late stage in drug development.
Will I know which treatment I'm receiving?
The study has different treatment groups. The research team will explain to you how the treatments are assigned and whether you will know which specific combination you are receiving.
Can I stop participating if I want to?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without having to explain why, and it will not affect your usual medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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