A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR).
This research is looking into a new treatment called [177Lu]-NeoB for people with advanced solid tumours where a specific marker called GRPR is present. It's an early-stage study, meaning it's one of the first times this treatment is being given to people. The main goals are to understand if the treatment is safe, how well the body can handle it, how it spreads inside the body, and if it has an anti-tumour effect. Doctors will closely monitor for any side effects and see if the tumours shrink. This study is crucial for learning more about new ways to fight cancer, and it's being conducted in multiple hospitals.
At a glance
What is this study about?
This study is exploring a new medicine called [177Lu]-NeoB for people who have advanced solid tumours. These are cancers that have grown beyond their original site and have a special marker on their cells called "GRPR." Think of GRPR like a lock on the cancer cell, and [177Lu]-NeoB is designed to be a key that fits right into it. The medicine contains a small amount of radiation, which is intended to target and damage the cancer cells specifically.
The study is being carried out in two main parts, called Phase I and Phase IIa. Phase I is all about safety – it’s the very first time this treatment is being given to people. Doctors will be looking very closely for any major side effects or problems. Once they understand the safety better, they move to Phase IIa, which focuses on whether the treatment can actually shrink tumours. They will also continue to watch for side effects.
Researchers want to understand how this new treatment behaves in the body. They'll be checking how much of the medicine goes to different organs, how long it stays there, and how much radiation each organ receives. This helps them to see if the treatment is working as intended and if it's generally well-tolerated. The ultimate goal is to find out if [177Lu]-NeoB could be a helpful new option for people with these specific types of cancer.
Key takeaways
- This study is for advanced solid tumours with a specific marker called GRPR.
- It's testing a new radiation-based medicine called [177Lu]-NeoB.
- The main goals are to check the drug's safety, how it moves in the body, and if it can shrink tumours.
- Participation involves regular hospital visits, blood tests, and scans.
- You can stop taking part at any time.
- It's an early-stage study, so results will help future research.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. Both men and women can take part.
Importantly, your advanced solid tumour must have a specific marker called "GRPR" present. This means your cancer cells are known to overproduce this marker. Additionally, your tumour must light up on a specific scan using a substance called [68Ga]-NeoB, which helps doctors see if the treatment could potentially target your particular tumour.
The research team will need to check your medical history and other test results to make sure this study is right for you and that you meet all the necessary requirements for safety and to ensure the study can get accurate results.
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 old or older?
- Do you have an advanced solid tumour?
- Has your tumour been tested and found to have the GRPR marker?
- Has your tumour shown uptake on a [68Ga]-NeoB scan?
- Are you able to attend regular hospital visits?
What does participation involve?
If you decide to take part in this study, you will receive the study medicine, [177Lu]-NeoB, which is given as an infusion (through a drip). Doctors will closely monitor you throughout the study. This will involve regular visits to the hospital or clinic. During these visits, the study team will perform various assessments.
These assessments will include blood tests to check your general health, how the medicine is moving through your body, and any potential side effects. You will also have scans to see how the treatment is affecting your tumour and how the medicine is distributed in your body. Your vital signs (like blood pressure and heart rate) and heart activity (ECG) will also be checked regularly. You might also be asked to provide urine samples.
Throughout the study, you'll be asked about any side effects you experience. The total duration of your participation, including follow-up visits, will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedFrance
Common questions
What is GRPR?
GRPR stands for "gastrin-releasing peptide receptor." It's like a specific 'address' or 'lock' found on the surface of some cancer cells, which the new drug is designed to target.
What does 'advanced solid tumours' mean?
This means cancers that originated in solid organs (like lungs, bowel, or breast) and have grown or spread beyond their original site.
What is the purpose of [68Ga]-NeoB scans?
This type of scan helps doctors see if your tumour has the GRPR marker the treatment is designed to target. It's like a test to see if the 'key' (the treatment) will fit your 'lock' (the tumour).
Will this drug cure my cancer?
This is an early-stage study, and while the aim is to find effective treatments, there's no guarantee the drug will cure your cancer. It's looking to see if it can slow down or shrink tumours.
Can I stop participating in the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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