FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer
This study is for patients with advanced bowel cancer, breast cancer, sarcoma, or penile cancer where previous treatments haven't worked. It's investigating a new medication, CC-3, which is a 'bispecific antibody'. This means it's designed to do two jobs: attach to cancer cells and also activate your body's immune cells (T-cells) to attack the cancer. The study will first find the safest and most effective dose of CC-3, then expand to treat more patients at that dose. Researchers hope CC-3 will have fewer side effects than similar treatments and offer a new way to fight cancer by also targeting the blood supply that feeds tumours.
At a glance
What is this study about?
This clinical trial is designed to test a new medication called CC-3, specially developed for people with advanced cancers like bowel, breast, sarcoma, or penile cancer where standard treatments have stopped working. The main goal is to find out if CC-3 is safe, what the best dose is, and if it can help fight the cancer.
CC-3 is a special type of medicine known as a 'bispecific antibody'. Think of it as a smart molecule with two different 'arms'. One arm is designed to attach to cancer cells, including those that make up the tumour's blood vessels. The other arm calls in your body's own immune cells, called T-cells, to join the fight. This double action means CC-3 aims to not only directly target cancer cells but also cut off their blood supply and boost your immune system's attack. Researchers hope this approach will be more effective and cause fewer side effects compared to other similar treatments.
The study will happen in two main parts. First, a small group of patients will receive increasing doses of CC-3 to find the highest dose that can be given safely. Once this safe dose is found, more patients will be given this specific dose to see how well it works against their cancer and to gather more information on its effects.
Key takeaways
- Tests a new 'smart' medicine (CC-3) for advanced cancers.
- Aims to activate the body's own immune system to fight cancer.
- Also designed to cut off the blood supply to tumours.
- Hopes to offer a new treatment option with fewer side effects.
- This is the first time CC-3 is being used in people.
- Study involves finding the safest dose and then testing its effectiveness.
Who may be eligible?
To join this study, you must have advanced bowel cancer (colorectal cancer) that has spread, breast cancer, sarcoma, or penile cancer. Your cancer must also have gotten worse even after you've had at least three different types of standard treatments. If you have bowel cancer, you would have already tried medicines like FOLFOX or FOLFIRI. If your bowel cancer has specific genetic markers (MSI-high/dMMR or BRAF V600E mutation), you would also need to have tried certain targeted therapies.
You also need to be at least 18 years old, and your general health should be good enough to take part. This means having good blood test results for your bone marrow, kidneys, and liver. Your doctors will check if your cancer can be measured and tracked with scans like CT or MRI. Women who could become pregnant and men with partners who could become pregnant must agree to use effective contraception during the study and for two months afterwards.
All participants must be able to understand the study information and agree to follow the study plan. You will need to sign a consent form, show up for appointments, and have the required tests. You cannot donate blood while on the study drug and for two months after your last dose.
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 bowel, breast, sarcoma, or penile cancer?
- Has your cancer progressed even after at least three previous treatments?
- Are you 18 years old or older?
- Are your kidney, liver, and blood functioning well?
- Are you able to attend regular clinic appointments and scans?
- Are you willing to use effective contraception if needed?
What does participation involve?
If you join this study, you will be given the experimental medicine, CC-3. The study involves regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment and to monitor for any side effects. These assessments will help the doctors understand the medicine's safety and effectiveness. The study has two phases: initially, small groups of patients will receive increasing doses of CC-3 to find the best dose. Once this is determined, more patients will receive that specific dose. The total duration of your participation will depend on various factors, including how you respond to the treatment, but you will be monitored through regular follow-up appointments.
Potential risks and benefits
Locations (1)
- University Hospital TuebingenVerified postcodeTübingen, Germany· Recruiting
Common questions
What is CC-3?
CC-3 is a new experimental medicine, a type of 'bispecific antibody', designed to help your immune system fight advanced cancer.
What types of cancer is this study for?
It's for people with advanced bowel (colorectal), breast, sarcoma, or penile cancer that hasn't responded to previous treatments.
What does 'first in human' mean?
It means this is the first time this specific medicine, CC-3, is being given to people, after extensive testing in labs.
Will I have more side effects than other treatments?
Researchers hope CC-3 will have fewer side effects due to its design, but as a new medicine, all potential effects are still being carefully studied.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.
How to find out more
Juliane Walz, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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