A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma
This research study is looking at a new treatment, SOT102, for people with advanced stomach or pancreatic cancer. It's an early-stage trial, exploring two main things. Firstly, the study aims to gently increase the dose of SOT102 to find the safest and most effective amount, both when given on its own and when combined with standard chemotherapy and other existing treatments. These standard treatments include medicines like Folinic Acid, Abraxane, Oxaliplatin, Opdivo, Gemcitabine, and Fluorouracil. Secondly, once the best dose is found, the study will check how well SOT102 works to shrink tumours. This research is important for finding new ways to treat these cancers.
At a glance
What is this study about?
This study is investigating a new medicine called SOT102 for people diagnosed with advanced stomach cancer (gastric adenocarcinoma or cancer at the junction of the food pipe and stomach) or pancreatic cancer. These are early-stage trials, meaning SOT102 hasn't been widely tested in humans yet, so the research will start by giving small doses and carefully increasing them.
The study has two main goals. The first part, called Phase 1, is all about safety and finding the right dose. Researchers will give SOT102 alone and in combination with current standard treatments (which might include medicines like Folinic Acid, Abraxane, Oxaliplatin, Opdivo, Gemcitabine, or Fluorouracil). They will carefully watch for any side effects to determine the highest dose that can be given safely without causing too many serious problems. This is known as the 'maximum tolerated dose,' and helps them choose the 'recommended Phase 2 dose' for further study.
The second part, Phase 2, builds on this information. Once the safest and most promising dose of SOT102 is identified, the study will expand to see how effective it is. They will measure if the treatment helps to shrink tumours in the body. They will also look at other important factors like how long the treatment keeps the cancer from growing, how long people live, and how the treatment affects their quality of life. This helps researchers understand the overall benefit of SOT102.
Key takeaways
- This study tests a new medicine, SOT102, for stomach and pancreatic cancer.
- It aims to find the safest dose of SOT102, both alone and with common cancer treatments.
- The study will also check if SOT102 helps shrink tumours and improves quality of life.
- It's an early-stage trial, meaning SOT102 is still being thoroughly investigated.
- Participation involves regular hospital visits for treatment, monitoring, and assessments.
Who may be eligible?
To join this study, you must be a patient diagnosed with certain types of stomach cancer (gastric adenocarcinoma or cancer where the food pipe meets the stomach) or pancreatic cancer.
All participants must be at least 18 years old. The study is open to both men and women.
There will be other detailed criteria, often including your general health, specific features of your cancer, and any other medical conditions you might have. These will be carefully checked by the study doctor to make sure the study is safe and suitable for you.
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 at least 18 years old?
- Have you been diagnosed with stomach cancer (gastric adenocarcinoma or GEJ) or pancreatic cancer?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you willing to potentially receive either SOT102 alone or SOT102 with other standard treatments?
- Are you generally well enough to take part in a clinical study?
What does participation involve?
If you decide to take part in this study, you will receive SOT102, either on its own or in combination with standard cancer treatments, depending on which part of the study you join. These treatments will be given at a clinic or hospital.
You will have regular appointments for check-ups, which will include blood tests, physical examinations, and scans (like CT or MRI scans) to see how you are responding to the treatment and to monitor for any side effects. You will also be asked to fill out questionnaires about your quality of life, which helps researchers understand how the treatment affects your daily living.
The duration of your participation will vary depending on how you respond to the treatment and the study phase. It involves regular visits for treatment and monitoring over a period of time, with follow-up appointments even after treatment stops.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedBelgium
Common questions
What is SOT102?
SOT102 is an investigational new medicine being tested in this study to see if it can help treat stomach and pancreatic cancer.
What is 'monotherapy' and 'standard of care'?
Monotherapy means receiving only SOT102. 'Standard of care' refers to the usual, established treatments for your cancer that doctors currently recommend.
What are 'Phase 1' and 'Phase 2' trials?
Phase 1 trials are early studies focusing on safety and finding the right dose. Phase 2 trials come next and look at how well the new treatment works and continue to monitor for side effects.
Will I know if I'm getting SOT102 or a different treatment?
In this study, you will receive SOT102, either alone or with standard treatments. The study is designed to explore SOT102 specifically.
What are 'side effects'?
Side effects are any unwanted or unexpected effects from the treatment. The research team will closely monitor you for any side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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