A PHASE 1 FIRST-IN-HUMAN OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY EFFICACY OF ERAS-0015 MONOTHERAPY AND IN COMBINATION IN PATIENTS WITH ADVANCED SOLID TUMORS
This is a Phase 1 clinical trial looking at an experimental cancer drug known as ERAS-0015. It is designed for adults with advanced solid tumours, which are cancers affecting solid organs such as the lungs, bowel, or breast that may have spread or stopped responding to standard treatments. Because this is a 'first-in-human' study, the main goal is to find out if ERAS-0015 is safe and what side effects it might cause. Researchers also want to understand how the body processes the drug and find the safest, most effective dose. Patients may receive ERAS-0015 on its own or alongside other cancer medications. Although the main focus is safety, doctors will also look closely for early signs that the treatment is helping to control or shrink tumours.
At a glance
What is this study about?
Solid tumours are lumps of cancer cells that can form in organs such as the lungs, liver, bowel, or breasts. When these cancers become advanced, they may spread to other parts of the body or stop responding to standard treatments like chemotherapy. When this happens, doctors look for new, innovative treatments through clinical trials.
This study is testing a new experimental medicine called ERAS-0015. It is a 'Phase 1' study, which means it is the very first time this drug is being given to humans. Before this stage, the drug has only been tested in laboratory settings. Because it is so new, the primary focus is finding out how safe the drug is, what side effects it causes, and what dose works best without making people too unwell.
During the trial, doctors will also study how the drug moves through the body and whether it affects cancer cells in the way scientists hope. Patients may take ERAS-0015 by itself or in combination with other treatments. While it is too early to know if ERAS-0015 will cure or shrink tumours, studies like this are crucial for developing new cancer therapies for the future.
Key takeaways
- Tests a new medicine called ERAS-0015 for the first time in humans.
- Open to adults aged 18 and older with advanced solid tumours.
- Main focus is to find the safest dose and check for side effects.
- No placebo is used; all participants receive the study medicine.
- Requires regular hospital visits and close health monitoring.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with an advanced solid tumour. It is generally aimed at people whose cancer has continued to grow despite standard treatments, or for whom suitable standard treatments are no longer available.
Because ERAS-0015 is being tested in humans for the first time, participants will need to be well enough in their day-to-day life to manage extra hospital visits and potential side effects. Your major organs, such as your heart, liver, and kidneys, will need to be working reasonably well to ensure you can safely process the medicine.
The trial team will check your full medical history and perform tests to make sure joining the trial is as safe as possible for you. Certain other medical conditions or recent treatments may mean this study is not suitable.
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 aged 18 or older.
- I have been diagnosed with an advanced solid tumour (cancer).
- My cancer has grown or standard treatments are no longer working for me.
- I feel well enough to manage regular hospital trips and tests.
- My doctor agrees that a clinical trial might be a suitable option for me.
What does participation involve?
If you take part, you will need to make regular visits to a specialist hospital or clinical trial centre. At the start, you will have health checks, including blood tests, physical examinations, and scans (such as CT or MRI scans) to check the size of your tumour and make sure you are safe to proceed.
You will be given ERAS-0015 either on its own or with other medicines, following a set schedule. Because this is an early-stage study, you will be monitored very closely, especially in the first few weeks. This means frequent hospital visits for blood tests to measure the drug levels in your body and check for side effects. You will continue the treatment as long as your cancer does not worsen and you do not experience unacceptable side effects, followed by a routine check-up period after treatment ends.
Potential risks and benefits
Locations (1)
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Common questions
What does 'first-in-human' mean?
It means this trial is the very first time the medicine is being tested in people. Previous tests were only carried out in laboratories.
Will I definitely receive the new medicine?
Yes. This is an 'open-label' study, which means there is no dummy pill (placebo). All participants will receive the active study medicine.
What is a solid tumour?
A solid tumour is an abnormal mass or lump of cancer cells in an organ, such as the lung, breast, or bowel. It differs from blood cancers like leukaemia.
How often will I need to go to the hospital?
Phase 1 trials usually require frequent visits, especially during the first few weeks, for close safety monitoring and blood tests. Your trial team will give you a detailed schedule.
Can I leave the study if I change my mind?
Yes. You have the right to leave the trial at any time for any reason. Doing so will not affect the quality of your regular NHS 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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