Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers
This clinical trial is looking at a new investigational medicine called IMC-R117C for people with advanced forms of certain cancers, including advanced bowel (colorectal), gullet (oesophageal), stomach (gastric), or ovarian cancer. The study is particularly for those whose cancer cells have a specific genetic marker (HLA-A*02:01) and produce a protein called PIWIL1. Researchers are testing IMC-R117C in two main ways: first, on its own, and then in combination with other existing cancer treatments. The main goals are to find out if this new drug is safe for patients and how well it works against these cancers. It's a 'first-in-human' study, meaning it's one of the first times this drug is being given to people, starting with initial safety checks before looking at its benefits.
At a glance
What is this study about?
This study is focused on people who have advanced cancer, specifically certain types like bowel (colorectal), gullet (oesophageal), stomach (gastric), or ovarian cancer. When we say 'advanced,' it means the cancer has spread or is difficult to treat with standard methods. The researchers are particularly interested in patients whose cancer cells have a specific marker, often called HLA-A*02:01, and produce a substance called PIWIL1. These markers help identify suitable patients for this new treatment approach.
The main treatment being tested is a new drug called IMC-R117C. This drug is designed to target cancer cells that have the PIWIL1 protein, while also potentially activating the body's immune system to fight the cancer. The study will look at how safe this new drug is when given on its own, and also when it's combined with other common cancer treatments like chemotherapy or drugs that block certain signals in cancer cells (kinase inhibitors) or stop new blood vessels from growing to feed the tumour (antiangiogenic agents). By combining them, doctors hope to find more effective ways to treat these advanced cancers.
This is called a 'Phase 1/2' study. Phase 1 is about making sure the new drug is safe and finding the right dose. Phase 2 then looks at how well the drug works against the cancer and continues to monitor its safety. The information gathered from this study is crucial for deciding if IMC-R117C could become a new treatment option for people with these difficult-to-treat cancers in the future. It’s an important step in developing new ways to help patients.
Key takeaways
- This study is testing a new drug for advanced bowel, gullet, stomach, or ovarian cancers.
- It's for people whose cancer has specific markers (HLA-A*02:01 and PIWIL1 protein).
- The drug aims to target cancer cells and potentially boost the immune system.
- It's a Phase 1/2 study, focusing on safety first, then how well it works.
- You must have tried standard treatments already to be considered for this trial.
Who may be eligible?
To join this study, your doctor will need to check if you meet certain requirements. You generally need to be 18 years or older and in reasonably good health, able to carry out your normal daily activities without much difficulty. Your specific type of advanced cancer must be confirmed, such as advanced bowel, gullet, stomach, or ovarian cancer. It's also vital that your cancer cells have a particular genetic marker called HLA-A*02:01. The doctors will also need a sample of your tumour tissue to confirm it has the PIWIL1 protein and that your cancer can be measured to see if the treatment is working. You should have already tried standard treatments for your cancer.
There are also reasons why you might not be able to join. For example, if you have cancer that has spread to your brain and is causing symptoms, or if you have recently had problems like a blocked bowel or fluid build-up that needed draining. You can't join if you have significant ongoing side effects from previous cancer treatments, or if certain blood tests are outside the normal range. Serious heart, lung, or autoimmune conditions, or needing medicines to suppress your immune system, would also prevent you from participating. If you are pregnant or breastfeeding, or if you are allergic to any part of the study medicine, you wouldn't be able to take part.
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 bowel, gullet, stomach, or ovarian cancer?
- Has your doctor confirmed your cancer has the HLA-A*02:01 marker?
- Are you generally well enough to go about your daily activities?
- Have you already received standard treatments for your cancer?
- Are you not pregnant or breastfeeding?
What does participation involve?
Taking part in this study means you would receive the investigational drug, IMC-R117C, either alone or with other cancer treatments. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These assessments help the doctors understand if the treatment is safe and working. The full duration of your participation in the study, including the treatment period and follow-up, will be explained by the study team. Both men and women who are able to have children must agree to use highly effective birth control methods during the study.
Potential risks and benefits
Locations (13)
- St Vincent's HospitalVerified postcodeDarlinghurst, Australia· Active not recruiting
- Peter MacCallum Cancer CentreVerified postcodeMelbourne, Australia· Recruiting
- Institut Jules BordetVerified postcodeAnderlecht, Belgium· Recruiting
- Universitair Ziekenhuis GentVerified postcodeGhent, Belgium· Recruiting
- UZ LeuvenVerified postcodeLeuven, Belgium· Recruiting
- Universitaetsklinikum HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSVerified postcodeRoma, Italy· Recruiting
- nstituto Clinico HumanitasVerified postcodeRozzano, Italy· Recruiting
- Antoni van LeeuwenhoekVerified postcodeAmsterdam, Netherlands· Recruiting
- Hospital HM Nou DelfosVerified postcodeBarcelona, Spain· Recruiting
- VHIO, Vall d'Hebron University HospitalVerified postcodeBarcelona, Spain· Recruiting
- Centro Integral Oncologico Clara CampalVerified postcodeMadrid, Spain· Recruiting
Common questions
What does 'HLA-A*02:01-positive' mean?
It means your body's cells, including your cancer cells, have a specific marker on their surface that helps your immune system recognise cells. This study particular targets this marker.
What is PIWIL1 and why is it important for this study?
PIWIL1 is a protein that is more commonly found in certain advanced cancers. This new drug, IMC-R117C, is specifically designed to target cancer cells that have this PIWIL1 protein.
What are 'Phase 1' and 'Phase 2' studies?
Phase 1 studies primarily check if a new drug is safe and find the right dose. Phase 2 studies then look at how well the drug works against the cancer while continuing to monitor safety.
Can I still join if I've had other treatments for my cancer?
Yes, in fact, you generally need to have already received the standard treatments for your type of advanced cancer to be considered for this study.
What if I experience side effects during the study?
The study team will closely monitor you for any side effects and provide appropriate medical care if you experience any. You should always tell them about any new or worsening symptoms.
How to find out more
Immunocore Medical Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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