A first-in-human, open-label, multicenter Phase I/II study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with advanced solid tumors (EXPAND-1)
This clinical trial is looking at an experimental cancer medicine called ANV600. It is being given to humans for the first time. The study is for adults with advanced solid tumours, which are cancers that form in organs or tissues and may have grown or spread. The main goal of the first part of the study is to find out what dose is safe, what side effects occur, and how the body handles the medicine. The second part looks at whether ANV600 can help shrink tumours or slow down cancer growth. Participants will receive ANV600 either on its own or alongside pembrolizumab (Keytruda), a common immunotherapy drug that helps the immune system fight cancer cells. Doctors will monitor everyone closely throughout treatment.
At a glance
What is this study about?
Solid tumours are cancers that form in solid organs or tissues, such as the lungs, bowel, or skin, rather than in the blood. When these cancers become advanced, standard treatments may stop working as well, and new options are urgently needed. This clinical study is testing an experimental medicine called ANV600 to find out if it can offer a new way to treat advanced cancers.
Because this is a 'first-in-human' trial, it is the first time ANV600 has been given to people. The study is split into two phases. Phase 1 focuses on safety: finding the right dose and watching closely for any side effects. Phase 2 checks how well the treatment works at shrinking tumours or stopping them from growing.
In the study, participants may receive ANV600 by itself, or they may receive it with another cancer drug called pembrolizumab (also known as Keytruda). Pembrolizumab is an immunotherapy, which means it helps the body's own immune system find and attack cancer cells. Researchers hope that combining both medicines might make them more effective together than alone.
Key takeaways
- Tests a new medicine (ANV600) for the first time in people.
- Open to adults aged 18 and older with advanced solid tumours.
- Compares ANV600 on its own and in combination with pembrolizumab.
- Focuses on checking safety, finding the best dose, and tracking tumour response.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to men and women aged 18 and older who have an advanced solid tumour. 'Advanced' usually means the cancer has spread to nearby tissue, spread to other parts of the body, or has not responded to standard treatments.
To take part, people generally need to be well enough to carry out daily activities and have functioning organs, such as healthy liver and kidney function. This helps make sure the body can safely handle an experimental medicine.
Not everyone will be able to join. For example, people with certain serious medical conditions, active infections, or those who are pregnant may not be suitable. The study team and your cancer specialist will review your full medical history to see if this trial is right 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.
- You are aged 18 or older.
- You have been diagnosed with an advanced solid tumour cancer.
- Standard cancer treatments are no longer working or suitable for you.
- You feel well enough to attend regular hospital appointments.
- You are willing to receive medicines via an intravenous drip.
What does participation involve?
Taking part in this study involves receiving the treatment through a drip into a vein (an intravenous infusion) at a hospital or specialist cancer centre. You may receive ANV600 alone or together with pembrolizumab. You will need to attend regular clinic visits for physical exams, blood tests, heart checks, and imaging scans (such as CT or MRI scans) to see how the cancer is responding.
Because this is an early-stage study, the team will monitor you very closely, especially in the first few weeks. The total length of time you take part will depend on how well your body tolerates the medicine and whether your cancer stays under control. You can stop taking the medicine or leave the trial at any time.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedNetherlands
Common questions
What is a 'first-in-human' trial?
It means this is the very first time this specific medicine is being tested in people, having previously only been tested in laboratory studies.
What is an advanced solid tumour?
It refers to a cancer that started in an organ or tissue (not blood) that has grown large, spread to other areas, or returned after previous treatment.
Will I have to pay for the trial treatment?
No, clinical trial medicines and study-related tests are provided free of charge, and travel expenses are often reimbursed.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time for any reason, and your medical team will continue to care for you.
What is pembrolizumab?
Pembrolizumab (Keytruda) is an established immunotherapy drug that encourages your body's immune system to attack cancer cells.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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