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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Adel Samson
+44 113 2068362
adel.samson@nhs.net


Prof Hardev Pandha
+44 1865-950220
clinicaloperations@accessiontherapeutics.com


Dr . Recruitment Enquiries
-
attest@precisionformedicine.com


Study Location:

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Be Part of Research - Trial Details - A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants with Select Epithelial Solid Tumours Under Multiple sub-protocols (ATTEST)

A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants with Select Epithelial Solid Tumours Under Multiple sub-protocols (ATTEST)

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Select solid epithelial tumour
Pancreatic cancer
Lung cancer
Bladder cancer
Head and neck cancer
Endometrial cancer
Cholangiocarcinoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a Phase 1-2 trial which is testing a new drug called ATTR-01 to find out if it may work to treat different types of cancer. ATTR-01 has not been approved as a medicine by any health authority.

What is ATTR-01 and how does it work?
ATTR-01 is a new drug designed to target cancer. ATTR-01 is made from a weakened adenovirus (Ad5). An Ad5 is a common human virus that causes cold like symptoms. Normally, an Ad5 will infect many cells in the body. ATTR-01 has been developed so that it should infect and only replicate (multiplies itself) in cancer cells. The drug is designed so that it does not kill healthy cells. This should make the drug better at killing cancer and cause fewer drug side effects. ATTR-01 is a type of immunotherapy (it stimulates the body’s immune system). ATTR-01 is injected into a patient participants’ blood stream. Once in the blood, ATTR-01 circulates and should infect cancer cells.
ATTR-01 may kill cancer cells in two ways:
1. Inside the cancer cell, ATTR-01 may force the cancer cell to make and release a potent (strong) drug. This drug can kill cancer cells by activating the body’s immune system to fight the cancer.
2. ATTR-01 may kill cancer cells when the virus replicates (it bursts the cancer cell).

Who can use ATTR-01?
ATTR-01 has been developed to bind to a receptor (a type of 'hook') on cancer cells. Not all cancer types have this receptor on their surface. Only people with cancers that usually have this receptor may receive ATTR-01.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

24 Feb 2025 15 Nov 2029

Trial visits will take place at hospitals taking part in the trial. This may require more visits to the hospital than are usual for cancer care, but expenses will be paid for by Accession Therapeutics. A participant may be followed up for up to approximately five years in total. In the last four years, most follow-up can be as phone calls with the trial doctor. Participants can have other cancer treatments after ATTR-01, without having to leave trial follow-up. Participants can withdraw from the trial at any time, without giving any reason. Medical care or legal rights of a participant will not be affected if they choose to withdraw.
The trial will involve having tests and procedures to check health and find out about the cancer. The tests will include blood and urine samples, tumour biopsies and scans. Participants who receive ATTR-01 will have swabs to see how ATTR-01 leaves the body (mouth and rectal swabs).
Accession Therapeutics will collect and use information (data) needed for the trial from the participants medical records and the samples they supply. Participant’s data will be de-identified to protect their privacy (this means data is linked to a unique study code, and not the participant’s actual name). The data that is held by Accession Therapeutics will be safely and securely stored on databases that are managed by it and the companies that work for Accession Therapeutics.


Adult patients with solid epithelial tumours who meet the inclusion criteria.

You can take part if:



You may not be able to take part if:


Master Protocol key exclusion criteria (additional sub-protocol specific criteria may apply):1. Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.2. Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and/or anti-PD-L1 immunotherapy due to toxicity.3. Has any of the comorbid conditions listed in the detailed exclusion criteria (MP or applicable SP).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Churchill Hospital
    Old Road Headington
    Oxford
    OX3 7LE
  • Velindre Cancer Centre
    Velindre Road
    Cardiff
    CF14 2TL
  • Royal Preston Hospital
    Sharoe Green Ln Fulwood
    Preston
    PR2 9HT
  • St James University Hospital
    Beckett Street Bexley Wing
    Leeds
    LS9 7TF
  • Beatson West of Scotland Cancer Centre
    1053 Great Western Rd
    Glasgow
    G61 1BD

This is the first time that ATTR-01 has been tested in humans. It is not yet known if the drug works or what the side effects may be. Participants that receive the drug may have mild cold-like symptoms, similar to receiving a vaccine. These could include fever, loss of appetite, tiredness, weakness, difficulty breathing, diarrhoea or inflamed bowel, feeling or being sick, skin changes (dryness, itching, rash), joint pains, urine infections and headaches. Taking part in a trial involves having more tests and hospital visits than in usual care. Taking part in research like this may not help you but may help other people with cancer in the future. There is no placebo drug in this trial.
It is not known if the virus may spread by sexual activity. The effect of ATTR-01 on unborn children or nursing infants is not known. For these reasons, participants must agree to the contraceptive requirements for the trial for up to a year after receiving the last dose of the drug.


The study is sponsored by Accession Therapeutics Limited and funded by Accession Therapeutics Limited.




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Read full details for Trial ID: ISRCTN38972074

Or CPMS 57739

Last updated 04 August 2025

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