All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

TT-702 in Patients With Advanced Solid Tumours.

This study is looking into a new treatment called TT-702 for different types of advanced solid tumours. During the first part of the study (Phase 1), doctors will carefully increase the dose of TT-702 to find the safest amount to give, both on its own and in combination with another cancer drug called darolutamide. They will also look for any side effects. In the second part (Phase 2), more people will receive the chosen dose to see how well it works and to check for further side effects in specific cancers like prostate, certain bowel cancers, and triple-negative breast cancer. The main goal is to find a safe and effective dose that might help people with their cancer.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Cancer Research UK
Enrolment target
188
Start
19 Jan 2022
Estimated completion
01 Jun 2027

What is this study about?

This study is investigating a new medication called TT-702 for people who have advanced solid tumours. Advanced solid tumours are cancers that have grown or spread. This new drug is designed to work by activating your body's own immune system to recognise and fight off cancer cells. It does this by blocking something called the 'A2B adenosine receptor', which acts like a switch to wake up your immune system.

The study has two main stages. In the first stage (Phase 1), a small number of patients will receive gradually increasing doses of TT-702. This is to find out the highest dose that can be given safely, both on its own and when combined with another existing cancer drug called darolutamide. Doctors will be checking for side effects and how the body handles the drug.

Once a safe dose is found, the study moves into the second stage (Phase 2). Here, more patients will receive this carefully chosen dose. This stage will look more closely at how effective TT-702 is, both alone in specific cancers (like certain prostate, bowel, and breast cancers) and in combination with darolutamide. The overall aim is to see if TT-702 can be a helpful new treatment option for people with advanced solid tumours.

Key takeaways

  • This study is for people with advanced solid tumours, including certain prostate, bowel, and breast cancers.
  • It's testing a new drug called TT-702, sometimes with another drug, darolutamide.
  • The main goals are to find a safe dose and see how well TT-702 works.
  • You'll have regular medical checks and tests if you join.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be able to understand the study and agree to take part, and be willing to provide blood and tissue samples. The doctors will estimate that you have at least 12 weeks of life expectancy and your general health should be good enough to participate.

For the first part of the study (Phase 1), you need to be at least 16 years old if you are receiving TT-702 by itself, or at least 18 years old if you are receiving TT-702 with darolutamide. Your cancer should be an advanced solid tumour that hasn't responded to standard treatments, or where standard treatments aren't suitable for you.

The doctors will also check your blood test results to make sure they are within certain healthy ranges. Your cancer should be measurable, meaning it can be seen and tracked through scans, and it should have shown signs of getting worse recently.

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 at least 16 (or 18 if combining drugs) years old?
  2. Do you have an advanced solid tumour that has recently progressed?
  3. Are you able to provide regular blood samples and potentially tissue samples?
  4. Do you have good general health and acceptable blood test results?
  5. Are you willing to follow the study schedule and attend appointments?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the study drug TT-702, and potentially darolutamide, according to a schedule decided by the research team. You will have regular visits to the hospital for assessments. These will include physical examinations, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Some patients, especially in the early stages, may also need to have tumour biopsies, which involve taking a small tissue sample from your tumour. The study aims to understand how your body processes the drug and how it's eliminated. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in, but you will have follow-up appointments.

Potential risks and benefits

Taking part in this study could offer the potential benefit of accessing a new treatment, TT-702, before it's widely available. This treatment might help to shrink your tumour or slow its growth. However, like all medications, TT-702 may have side effects, which the study will carefully monitor and try to manage. There's no guarantee that the treatment will work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Marsden Hospital NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie NHS Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Recruiting
  • University Hospital Southampton NHS Foundation Trust
    Verified postcode
    Southampton, United Kingdom· Recruiting

Common questions

What is TT-702?

TT-702 is a new experimental drug being investigated for advanced solid tumours. It aims to boost your immune system to fight cancer.

What are "advanced solid tumours"?

These are cancers that started in an organ and have either grown larger or spread to other parts of the body.

What is darolutamide?

Darolutamide is an existing medicine used to treat prostate cancer. In this study, it's being tested in combination with TT-702 for certain prostate cancers.

What does 'Phase 1' mean?

Phase 1 is the first stage of testing a new drug in humans. It focuses on finding a safe dose and understanding side effects.

What kind of tests will I have?

You'll have physical exams, blood tests, scans, and possibly tumour biopsies to check your health and how the treatment is working.

How to find out more

Johann de Bono, Prof

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 "TT-702 in Patients With Advanced Solid Tumours.…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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