A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
This research study is investigating a new combination treatment for people with advanced stomach cancer or cancer where the food pipe meets the stomach (gastroesophageal junction cancer). The new treatment involves a drug called S095029, which is being testing alongside pembrolizumab (Keytruda®), a medicine already used to treat some cancers. Researchers want to find out if this combination is safe and how well it can fight the cancer. This study is specifically for cancers that have certain genetic features known as MSI-H/dMMR. It will first look at the best dose of S095029 to use, and then see how effective the treatment is in a larger group of patients. The goal is to find better treatment options for these specific cancer types.
At a glance
What is this study about?
This research study is exploring a new way to treat advanced stomach cancer or cancer found at the meeting point of your food pipe and stomach (called gastroesophageal junction cancer). These are cancers that doctors can't remove with surgery or have spread to other parts of the body.
The study involves a new drug, S095029, which is being given together with pembrolizumab, a treatment that's already used for some cancers. Pembrolizumab works by helping your body's immune system fight cancer. Researchers want to see if adding S095029 to pembrolizumab makes the treatment more effective and safe, specifically for a type of cancer that has particular genetic features called MSI-H/dMMR. This means the cancer cells have trouble repairing mistakes in their DNA.
The study is divided into two main parts. The first part will help doctors find the safest and most effective dose of S095029 when given with pembrolizumab. Once that dose is found, the second part of the study will involve more people to see how well this combination treatment works against their cancer and to continue monitoring its safety. The overall aim is to find better treatment options for people living with these specific types of stomach and gastroesophageal junction cancers.
Key takeaways
- This study is for advanced stomach or gastroesophageal junction cancer.
- It's for cancers with specific genetic markers (MSI-H/dMMR).
- It tests a new drug (S095029) combined with an existing one (pembrolizumab).
- The focus is on safety and how well the treatment works.
- Participation involves regular clinic visits and monitoring.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must have an official diagnosis of stomach cancer or gastroesophageal junction cancer that is advanced, meaning it cannot be removed by surgery or has spread. Your cancer must also have a specific genetic feature called MSI-H/dMMR, which your doctor will have tested for.
There are also some reasons why you might not be able to join. For example, if you've already had more than one line of treatment for your advanced cancer, or if you've previously received certain types of immunotherapy drugs, like those that target PD-1, PDL1, or CTLA4, you would not be eligible.
Also, if you've recently had other cancer treatments, such as chemotherapy or radiation therapy (within a few weeks before the study starts), or major surgery (in the last four weeks), you wouldn't be able to begin the study until enough time has passed for your body to recover.
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.
- Do you have advanced stomach or gastroesophageal junction cancer?
- Has your cancer been tested and confirmed to be MSI-H/dMMR?
- Have you had no more than one previous treatment for your advanced cancer?
- Have you not received certain types of immunotherapy drugs before?
- Have you recently recovered from any major surgery, radiation, or other cancer treatments?
What does participation involve?
If you join this study, you will receive two different medications: S095029 and pembrolizumab. The first part of the study will involve regular visits to the clinic so doctors can carefully monitor how you respond to the treatment and identify the best dose of S095029 to use. This will involve blood tests, scans, and other check-ups.
Once the ideal dose is found, the study will continue with more people. You will continue to have regular clinic visits, receive your study medications, and undergo various assessments to check how your body is handling the treatment and whether the cancer is responding. These assessments will include regular scans (like CT scans) to measure the size of your tumour(s). The total time you spend on the study can vary, but doctors will continue to monitor you even after treatment, to keep an eye on your progress and any side effects.
Potential risks and benefits
Locations (49)
- Ocala Oncology Center PlVerified postcodeOcala, United States
- Investigative Clinical Research of Indiana, LlcVerified postcodeNoblesville, United States
- MD Anderson Cancer CenterVerified postcodeHouston, United States
- The Queen Elizabeth HospitalVerified postcodeWoodville South, Australia
- Med Universitat Wien-Allgemeines Krankenhaus Der Stadt Wien (AKH)Verified postcodeVienna, Austria
- Ordensklinikum LinzVerified postcodeLinz, Austria
- Landeskrankenhaus (SALK)Verified postcodeSalzburg, Austria
- UZ Leuven Campus GasthuisbergVerified postcodeLeuven, Belgium
- Chu de LiegeVerified postcodeLiège, Belgium
- Cepon - Centro de Pesquisas OncologicasVerified postcodeFlorianópolis, Brazil
- Supera OncologiaVerified postcodeSanta Catarina, Brazil
- Icesp - Instituto Do Câncer Do Estado de São PauloVerified postcodeSão Paulo, Brazil
Common questions
What kind of cancer is this study for?
This study is for advanced stomach cancer or cancer where the food pipe meets the stomach, specifically if it has certain genetic features called MSI-H/dMMR.
What drugs are being tested?
Researchers are testing a new drug called S095029 together with an existing treatment called pembrolizumab (Keytruda®).
What does MSI-H/dMMR mean?
It refers to a specific genetic characteristic of your cancer that doctors test for. It means the cancer cells have difficulty repairing errors in their DNA.
Is this a new treatment?
S095029 is a new drug, and this study aims to see how well it works when combined with pembrolizumab, which is already used for some cancers.
Will I get the new drug?
Yes, if you meet the study's requirements, you will receive both S095029 and pembrolizumab as part of the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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