All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

First in Human Study of T3P-Y058-739 (T3P)

This study is testing a brand new treatment called T3P for people with advanced solid tumours, which are cancers that have spread or are difficult to treat. It's the very first time this treatment is being tried in humans, so the main goals are to check how safe it is and if different doses work, as well as to see if it shows any promise against the cancer. We'll be looking at T3P on its own, given in two different ways: directly into the tumour (an injection) or into the bloodstream (an infusion). We'll also be testing T3P combined with an existing cancer drug called pembrolizumab. The study is open to adults aged 18 to 74 who meet specific health requirements for their advanced solid tumours.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
T3 Pharmaceuticals AG
Enrolment target
100
Start
26 Apr 2022
Estimated completion
15 Oct 2027

What is this study about?

This study is designed to explore a new treatment called T3P for advanced solid tumours. "Advanced" means the cancer has either grown significantly, spread to other parts of the body, or hasn't responded to previous treatments. "Solid tumours" are growths of abnormal cells, unlike blood cancers. T3P is a specially modified type of bacteria related to a common gut germ, but it's been changed so it can potentially target and fight cancer cells. It's a very early stage of research, often called a 'first-in-human' study, which means it's the first time this specific treatment is being given to people.

The main aims of this study are to find out if T3P is safe for people, to work out the best dose to give, and to see if it shows any early signs of helping to treat advanced solid tumours. The study will gradually expand over several parts, starting with T3P given on its own: either directly into a tumour through an injection, or into the bloodstream through a drip. Based on what we learn, the study may then look at T3P combined with pembrolizumab, which is a common immunotherapy drug already used to treat certain cancers. To help the T3P bacteria work, you would also receive a small amount of a substance called desferrioxamine, which provides a key nutrient for the bacteria.

After your treatment periods are complete, you would be given antibiotics to clear any remaining T3P bacteria from your body. This careful approach helps us understand how T3P works safely and effectively, providing crucial information for potentially developing new treatments for advanced solid tumours in the future.

Key takeaways

  • This is a first-time test of T3P for advanced solid tumours.
  • The study aims to check safety, find the right dose, and see if it helps.
  • T3P might be given alone or with another drug, pembrolizumab.
  • Treatment involves injections or drips, plus antibiotics afterwards.
  • Close monitoring with tests and scans will be part of your participation.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for both men and women aged 18 to 74 who have advanced solid tumours. To be considered, your doctor must confirm that your cancer has been diagnosed through a tissue sample and that there are currently no standard treatments that would cure your condition or are suitable for you. You should also be generally well enough to take part in a study, meaning you can carry out most of your normal daily activities without too much difficulty.

Your recent health and medical history are also important. For example, you should have at least one tumour that can be directly injected, and you must not have certain other serious health issues, such as cancer that has spread to your brain or spinal cord, or a weakened immune system. It's also important that your body's organs, like your kidneys and liver, are working well enough to safely participate.

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. Are you between 18 and 74 years old?
  2. Do you have an advanced solid tumour for which there are no easy treatment options?
  3. Do you feel well enough to carry out most of your daily activities?
  4. Are your body's main organs (like liver, kidneys) working okay?
  5. Do you have a tumour that can be safely injected by a doctor?
  6. Have you discussed any existing serious health conditions with your doctor, such as a weakened immune system or cancer spread to your brain?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, it's divided into several parts, and your specific journey will depend on which part you are in. Initially, you might receive T3P either as an injection directly into one of your tumours or as a drip into your vein. You would also receive small doses of desferrioxamine, a substance to help the T3P treatment. After your treatment, you will be given antibiotics to clear the T3P from your body.

Throughout the study, you would attend regular appointments for physical examinations, blood tests, and scans (like CT or MRI) to see how your body is reacting to the treatment and whether the tumour is changing. The study involves many hospital visits as it's a new treatment, and the doctors need to monitor you closely. The exact number of visits and the total length of time you'd be involved can vary depending on your treatment response and the study's design. You'll also have a follow-up period after your main treatment to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial like this may offer you access to a new treatment before it's widely available. While we hope the treatment will be helpful, there's no guarantee that T3P will improve your cancer or even stop it from getting worse, as this is an early-stage study. Like all medical treatments, T3P could have side effects, which might be mild or more serious, and these will be closely monitored by the study team. You will be given detailed information about these potential risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Clinica Universidad de Navarra
    Verified postcode
    Pamplona, Spain· Recruiting
  • Vall d'Hebron Institute of Oncology
    Verified postcode
    Barcelona, Spain· Recruiting
  • Institut Catala D'oncologia
    Verified postcode
    L'Hospitalet de Llobregat, Spain· Recruiting
  • Clinica Universidad de Navarra
    Verified postcode
    Madrid, Spain· Recruiting
  • Hospital Universitario 12 De Octubre
    Verified postcode
    Madrid, Spain· Recruiting
  • Hospital Universitario La Paz
    Verified postcode
    Madrid, Spain· Recruiting
  • START Madrid-CIOCC Hospital Univ. HM Sanchinarro
    Verified postcode
    Madrid, Spain· Recruiting
  • Hospital Clínico Universitario de Valencia (INCLIVA)
    Verified postcode
    Valencia, Spain· Recruiting
  • University Hospital Bern (Inselspital)
    Verified postcode
    Bern, Switzerland· Recruiting
  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
    Verified postcode
    Lausanne, Switzerland· Recruiting
  • University Hospital of Zürich (Universitätsspital Zürich)
    Verified postcode
    Zurich, Switzerland· Recruiting
  • Cancer Research UK Clinical trials; Unit Partner in CaCTUS- Cancer clinical trials Unit Scotland; Beatson West of Scotland Cancer Centre
    Verified postcode
    Glasgow, United Kingdom· Recruiting

Common questions

What is an advanced solid tumour?

An advanced solid tumour is a cancer that has spread from where it started, or has become difficult to treat with standard methods.

What is T3P and how does it work?

T3P is a specially changed type of bacteria that scientists hope can help fight cancer cells. It's being tested for the first time in humans.

Will I get T3P on its own or with another drug?

The study starts by testing T3P on its own. Later, it might also be tested with an existing cancer drug called pembrolizumab, depending on early results.

How will the T3P be given to me?

It could be given in two ways: either injected directly into a tumour or given through a drip into your bloodstream.

Will I have to stay in hospital?

You will need to attend many hospital visits for treatment and check-ups, but it doesn't necessarily mean a long hospital stay each time.

How to find out more

Chief Medical Officer (CMO)

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

Interested in taking part?

Register your interest

Share your details and the research team for "First in Human Study of T3P-Y058-739 (T3P)…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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