At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab+T3P-Y058-739 (drug), T3P-Y058-739 (IV) (drug), T3P-Y058-739 (IT) (drug)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Pembrolizumab+T3P-Y058-739 — drug: intravenous infusion or intratumoural injection · T3P-Y058-739 (IV) — drug: Intravenous infusion · T3P-Y058-739 (IT) — drug: Intratumoral use
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a first-in-human study of a new treatment called T3P-Y058-739 (T3P), made by T3 Pharmaceuticals AG, for people with advanced solid tumours that cannot be removed by surgery and cannot be cured. T3P is injected directly into a tumour. Because it is the first time this treatment is given to people, the study will look at how safe it is and how people cope with it.
Who can take part
- You have an advanced solid tumour that cannot be removed by surgery, cannot be cured, and no other suitable treatment is available. This must be confirmed by testing a sample of the tumour.
- You have at least one tumour that can be measured and can be injected directly (for example, it can be seen, felt, or found with an ultrasound scan).
- You are 18 or older.
- You are reasonably well and active (performance status 0 or 1, a scale doctors use).
- Doctors expect you to live at least 12 more weeks.
- Side effects from earlier treatments or surgery have mostly cleared up (apart from hair loss).
- You have healthy levels of iron in your body and your organs (such as liver and kidneys) are working well.
- You are able to give informed consent and follow the study rules.
Who may not be able to
- You have another cancer that could affect taking part, unless it was successfully treated more than 2 years ago (some skin cancers and very early cancers may still be allowed).
- You have cancer that has spread to the brain or spinal cord.
- You have had a bone marrow or stem cell transplant from a donor, have a weakened immune system, or take medicines that suppress the immune system (including steroid tablets).
- You have an active infection, or you have HIV, hepatitis B or hepatitis C.
- You have had a Yersinia infection in the last 12 weeks, or the bacteria is found in a stool sample before treatment.
- You have recently taken antibiotics that could kill the T3P treatment (you must wait at least 5 half-lives after the last dose).
- You have heart valve disease, an aneurysm, artificial heart valves or implants that cannot easily be removed (such as joint replacements), or a past infection of the heart lining (endocarditis).
- You have a serious autoimmune condition, major heart rhythm or blood flow problems, heart failure, or a heart procedure (angioplasty) in the last 6 months.
- You are allergic to chloramphenicol, or to all of these antibiotics: co-trimoxazole, doxycycline, ceftriaxone and cefotaxime.
- You have had a serious allergic reaction to desferrioxamine.
- You have another serious medical or mental health problem, or take blood-thinning medicines, that could make joining the study risky or affect the results.
- You have a bleeding condition or take full-dose blood thinners, unless the tumour to be injected is near the surface and low risk for bleeding. Lower doses, aspirin or clopidogrel may be allowed.
- You have had a severe allergic reaction to checkpoint inhibitors or other monoclonal antibody treatments.
- You have had severe immune-related side effects lasting more than 12 weeks. Any such side effects must have cleared up, with no steroid treatment for at least 2 weeks before starting.
- You have a history of lung disease or lung inflammation that needed steroid treatment.
- You are at high risk of a hole (perforation) in the bowel, or have had sudden diverticulitis, an abscess in the tummy, or widespread cancer in the abdomen.
What taking part involves
- • T3P is injected directly into a tumour (called an intratumoural or IT injection). The tumour must be one that can be seen, felt, or found with ultrasound, and reached with a needle.
- • Injections may be done with the help of ultrasound or other scans to guide the needle.
- • T3P should be given into a vein in the arm rather than a central line (a tube in a larger vein), where possible.
- • The trial has at least two parts (Part A is mentioned); details of later parts are not stated — ask the trial team.
Time commitment: Number of visits, how long the study lasts, and how often injections are given are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 74 Years
- Who
- All
- Number of participants
- 100
- Started
- 2022-04-26
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for advanced solid tumor
- • Phase1/Phase2 - 100 participants
- • This is a first in human, phase I/II open-label, dose-finding, safety, and proof-of-concept clinical trial of T3P-Y058-739, a genetically-modified, live attenuated strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumors
Who can take part?
- • Ages 18 Years to 74 Years
- • Diagnosed with advanced solid tumor
Where?
- • Glasgow - Cancer Research UK Clinical trials; Unit Partner in CaCTUS- Cancer clinical trials Unit Scotland; Beatson West of Scotland Cancer Centre
- • Leeds - Leeds Clinical Research Facility
- • London - Royal Marsden NHS Foundation Trust
- • Southampton - University Hospital Southampton NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a first in human, phase I/II open-label, dose-finding, safety, and proof-of-concept clinical trial of T3P-Y058-739, a genetically-modified, live attenuated strain of the bacterium Yersinia enterocolitica, in patients with advanced solid tumors.
More detail
The study, which has a modular design with up to 6 parts, anticipates enrolling approximately 100 participants. Part A will open first. Part B and subsequent parts will open later. The study will evaluate T3P-Y058-739 monotherapy given by intratumoural (IT) injection (Part A) and by intravenous (IV) infusion (Part B). In addition, either IT or IV T3P-Y058-739 (route of administration to be chosen based on emerging data) will be evaluated in combination with pembrolizumab. All patients will receive low doses of desferrioxamine (which provides iron in a form that can be used by the bacteria) to support bacterial survival and growth. All patients will receive antibiotics on completion of therapy to eradicate any residual T3P-Y058-739.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 74 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ or surgical procedure to baseline
What the study is looking for
- ✓Histologically- or cytologically-proven advanced, unresectable solid tumour for which there is no curative therapy...
- ✓At least one measurable lesion
- ✓Male or female, 18 years of age or older at the time of signing agreement to take part.
- ✓activity scale (ECOG) performance status 0 or 1.
- ✓Estimated life expectancy of ≥12 weeks.
Who cannot take part
- ✗Known central nervous system (CNS) metastases.
- ✗Patients with a documented Yersinia infection in the 12 weeks prior to treatment or with detectable Y....
- ✗Patients who have recently received antibiotics that could affect the viability of T3P (at least 5 half-lives should...
- ✗Patients who are allergic to chloramphenicol or to all of the following antibiotics: co-trimoxazole, doxycycline,...
- ✗History of hypersensitivity to desferrioxamine
See the full criteria
Where Is This Study? (4 UK sites)
Cancer Research UK Clinical trials; Unit Partner in CaCTUS- Cancer clinical trials Unit Scotland; Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Leeds Clinical Research Facility
Leeds LS9 7TF, United Kingdom
Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Chief Medical Officer (CMO)
Sponsor contactCONTACT
Head Clinical Operations
Sponsor contactCONTACT
