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AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

First-in-human study of ATX-898 as monotherapy and in combination with other anti-neoplastic agents, in participants with advanced solid tumors

This study is a Phase 1 and 2 trial testing a new experimental medicine named ATX-898. It is designed for adults living with advanced solid tumours—meaning cancers that have grown or spread to other parts of the body. Because ATX-898 has not been given to people before, the main goal is to check how safe it is and find the right dose. The trial tests ATX-898 on its own and also in combination with established cancer treatments, such as Kisqali, Verzenios, or Fulvestrant. Doctors will carefully track side effects and monitor whether the treatment helps shrink tumours or stop them from growing. Taking part involves regular hospital visits, health checks, blood tests, and scans to ensure patient safety every step of the way.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
Antares Therapeutics Inc.
Enrolment target
68
Start
05 Oct 2026

What is this study about?

When cancer treatments stop working, doctors look for new ways to target and slow down cancer cells. This clinical trial investigates a brand-new medicine called ATX-898. It is being tested in people for the very first time. The study focuses on advanced solid tumours, which are cancers forming firm lumps in organs or tissues that may have spread.

The trial is split into two main parts. In the first part, doctors will test ATX-898 alone at low doses, slowly increasing the amount to find the safest and most effective dose. In the second part, the drug will be tested alongside other approved cancer medicines, such as Kisqali, Verzenios, or Fulvestrant, to see if combining them works well against tumours.

Because this is an early-phase trial, the primary focus is always on patient safety. Researchers want to understand how the human body processes ATX-898, what side effects it might cause, and whether it shows promising signs of shrinking tumours or slowing cancer growth.

Key takeaways

  • Tests a new medicine, ATX-898, in humans for the first time.
  • Open to adults aged 18 and older with advanced solid cancers.
  • Aims to find the safest dose and monitor any side effects.
  • Tests ATX-898 both alone and combined with standard cancer therapies.
  • Involves frequent hospital visits, blood tests, and scans.
  • Participation is completely voluntary and you can leave at any time.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with an advanced solid tumour. An advanced tumour means the cancer has either grown locally into nearby tissues or spread to other areas of the body, and standard treatments may no longer be working.

To be eligible, participants generally need to be well enough to carry out day-to-day activities and attend regular hospital visits. Doctors will check each person's general health, including how well their heart, liver, and kidneys are functioning.

People may not be able to join if they have certain serious medical conditions, uncontrolled infections, or if they are currently receiving other cancer treatments that could interfere with the study medicines. A doctor will carefully review each person's medical history to see if the trial is a safe choice for them.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with an advanced solid tumour cancer.
  3. My cancer has grown or spread, and I need new treatment options.
  4. I am well enough to attend regular hospital appointments.
  5. I am open to trying an experimental medicine under close medical observation.
Answer every question to see your result.

What does participation involve?

Taking part in this study involves close medical supervision at a specialist hospital. Participants will receive ATX-898 either on its own or together with another cancer medicine, taken as tablets or given as injections. Before starting, you will have baseline health checks, including blood tests, physical exams, heart traces (ECGs), and imaging scans such as CT or MRI scans. During the trial, you will need to attend frequent clinic visits so the medical team can monitor your vital signs, check for side effects, and see how your body breaks down the medicine. Scans will be repeated at regular intervals to see how the tumour responds. Treatment can continue for as long as it helps you and does not cause severe side effects, followed by regular check-ins once treatment ends.

Potential risks and benefits

Because ATX-898 is being tested in humans for the first time, its full side effects are not yet known, which is an important risk to consider. You may also experience common cancer treatment side effects from the other medicines, such as tiredness, sickness, or changes in blood counts. The potential benefit is that the treatment could help stabilise or shrink your cancer, though this cannot be guaranteed. Your participation also helps researchers discover new ways to treat cancer in the future. Joining the trial is entirely voluntary, and you are free to leave at any time without your regular NHS care being affected.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Netherlands
  • —
    Unverified
    Spain
  • —
    Unverified
    France
  • —
    Unverified
    Italy

Common questions

What does a 'first-in-human' study mean?

It means the medicine has been tested in laboratory studies before, but this is the very first time it is being given to people. Doses start very low to protect your safety.

What is a solid tumour?

A solid tumour is an abnormal mass or lump of tissue formed by cancer cells, such as in the breast, lung, or bowel. It is different from blood cancers like leukaemia.

Will taking part cure my cancer?

Early-phase trials focus mainly on finding safe doses and checking side effects rather than finding a cure. While it may help control tumour growth, this cannot be promised.

Do I have to pay to take part in the trial?

No, the study medication and trial-related tests are provided free of charge. Some trials also help cover travel expenses for hospital visits.

Can I stop taking part if I change my mind?

Yes, you can leave the study at any time for any reason. Your medical team will support your decision and discuss standard treatment options with you.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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