A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors
This trial is testing an experimental medicine called GEN1042 for adults with solid tumours, such as lung, bowel, or skin cancer. Because this is a 'first-in-human' study, it is the first time the drug is being given to people. The main goal is to find out what dose is safe, what side effects it might cause, and how the body handles it. Participants may receive GEN1042 on its own or alongside standard cancer treatments, such as chemotherapy or immunotherapy drugs. Researchers will closely watch how tumours respond to see if the treatment helps keep the cancer under control. Joining an early trial like this means extra hospital visits and regular tests so doctors can monitor your health very carefully.
At a glance
What is this study about?
When solid tumours grow or spread, standard treatments do not always work as well as doctors hope. Researchers are developing new medicines designed to attack cancer cells in different ways. This clinical trial focuses on a new drug called GEN1042. It is designed to treat various types of malignant solid tumours, which are cancerous lumps found in organs or tissues.
Because GEN1042 has not been tested in humans before, this study starts with small doses in a few people. Doctors gradually increase the dose in new groups of patients to find the highest amount that is safe and tolerable. Once a safe dose is identified, more people will receive it to see how well it works. In some groups, GEN1042 is given alone; in others, it is combined with familiar chemotherapy or immunotherapy drugs.
This trial matters because finding safe and effective new treatments is essential for improving cancer care. If GEN1042 proves to be safe and shows signs of slowing or shrinking tumours, it could move on to larger trials and potentially become a new treatment option for people facing advanced cancer.
Key takeaways
- Tests a brand-new cancer medicine called GEN1042 for the first time in people.
- Aims to find the safest dose and check how well it treats solid tumours.
- Open to adults aged 18 and over with advanced solid cancers.
- Medication is given via an intravenous drip, either alone or with standard cancer drugs.
- Involves frequent hospital visits, regular blood tests, and imaging scans to protect your safety.
- Taking part is voluntary, and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have a confirmed solid tumour cancer. It is mainly for people whose cancer is advanced, has spread, or has not responded well to standard therapies.
Because this is an early safety study, participants must be well enough to carry out daily activities and have reasonably healthy heart, kidney, and liver function. Your doctor will run blood tests to make sure your body can handle the treatment.
People with certain medical conditions, serious active infections, or women who are pregnant or breastfeeding may not be able to join. The trial team will review your full medical history to confirm whether this 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.
- I am 18 years of age or older.
- I have been diagnosed with a solid tumour cancer.
- My cancer is advanced, has spread, or has not responded to previous treatments.
- I am well enough to manage my daily self-care and light activities.
- I am willing to attend frequent hospital appointments for tests and infusions.
What does participation involve?
Taking part in this trial involves regular visits to a hospital or specialised clinical trial unit. The study medicines, including GEN1042, are given as an infusion into a vein (an IV drip). You may receive treatment on specific days every few weeks, depending on which group you are in.
During your visits, you will have regular health checks, including blood tests, physical examinations, and heart checks (ECGs). You will also have imaging scans, such as CT or MRI scans, every few weeks to measure your tumour and see how it is responding. The trial team will also take blood samples to see how quickly the medicine enters and leaves your body.
Your participation can continue for as long as the treatment helps you and does not cause troublesome side effects. You can expect to be in the study for several months, followed by check-ups to track your health over time.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedDenmark
Common questions
What does a 'first-in-human' study mean?
It means this is the very first time the experimental drug is being given to people. It has already been tested extensively in laboratories to ensure it is as safe as possible to begin human testing.
Will I be given a dummy drug (placebo)?
No. In this trial, every participant receives active treatment. No one is given an inactive dummy treatment (placebo).
How often will I need to visit the hospital?
You will need to visit the clinic quite often, especially during the first few weeks, for treatment infusions, blood tests, and scans. Your study team will give you a clear schedule.
Will I have to pay for the trial treatment?
No. The trial medication and all study-related tests are provided free of charge. Some studies also help with travel expenses.
Can I leave the study if I feel it is too much for me?
Yes. You have the right to leave the trial at any point, for any reason. Your regular medical team will discuss other care options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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