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Looking for participantsPhase1/Phase2

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

Sponsor: T3 Pharmaceuticals AG

NCT ID: NCT05120596

View on ClinicalTrials.gov ↗

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.

Advanced Solid Tumor

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

CD20serologically positive

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
Inclusion Criteria: 1. Histologically- or cytologically-proven advanced, unresectable solid tumour for which there is no curative therapy and no alternative therapy is felt to be appropriate. 2. At least one measurable lesion 3. Male or female, 18 years of age or older at the time of signing informed consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 5. Estimated life expectancy of ≥12 weeks. 6. Resolution of all acute reversible toxic effects of prior therapy or surgical procedure to baseline or Grade ≤1 (except alopecia). 7. Adequate iron stores without significant iron overload 8. Adequate organ function 9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 10. At least one lesion that is measurable according to iRECIST/RECIST 1.1 and amenable to direct IT injection, i.e., a lesion that is visible, palpable, or detectable by ultrasound, and accessible for direct IT injection (injection via an endoscope is not allowed for Part A at least; ultrasound and/or radiological guidance is allowed). Exclusion Criteria: 1. Current or prior malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, are generally eligible. 2. Known central nervous system (CNS) metastases. 3. Patients who have previously received an allogeneic bone marrow or stem cell transplant or with congenital or acquired immunodeficiency or receiving immunosuppressive therapy (including any dose of systemic corticosteroids). Patients should have recovered immunologically from any prior immunomodulatory therapies such as CD20-targeted antibodies. Patients receiving inhaled corticosteroids for asthma or chronic obstructive pulmonary disease, and patients on steroid replacement therapy (e.g. due to prior adrenalectomy or hypophysectomy) are eligible at the investigator's discretion. Patients likely to require immunosuppressive treatment with systemic steroids or other agent (e.g., patients with frequent exacerbations of asthma) should not enter the study. 4. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection. Patients with recent major infection (such as pneumonia in the previous 4 weeks) should have recovered to preillness levels with resolution of reversible infection-related symptoms for at least one week prior to starting T3P. 5. Patients with a documented Yersinia infection in the 12 weeks prior to treatment or with detectable Y. enterocolitica in a baseline stool sample (based on routine culture at site). 6. Patients who have recently received antibiotics that could affect the viability of T3P (at least 5 half-lives should have elapsed since the last dose). 7. Patients with known cardiac valvular disease or arterial aneurysms, artificial heart valves and other implanted prostheses (such as joint replacements) that cannot be easily removed or replaced. Patients with central venous access devices are allowed in the study but T3P should be administered by peripheral vein, whenever possible. Patients with a history of bacterial endocarditis, regardless of the organism, are excluded from the study. 8. Patients with a history of clinically significant autoimmune conditions, major cardiac arrhythmia or ischaemia, requiring any form of regular or "as needed" medication to control symptoms, New York Heart Association class II, III or IV cardiac failure or coronary angioplasty in the previous 6 months. 9. Patients who are allergic to chloramphenicol or to all of the following antibiotics: co-trimoxazole, doxycycline, ceftriaxone and cefotaxime. 10. History of hypersensitivity to desferrioxamine 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or T3P administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. This includes patients on treatment with anticoagulants within 6 months prior to study entry for thromboembolic events. 12. Patients with a bleeding diathesis or receiving therapeutic doses of anticoagulants unless the lesion(s) to be injected are superficial and at low risk of bleeding. Patients receiving lower doses of anticoagulants, aspirin or clopidogrel may be eligible at the investigator's discretion, depending on the site of lesions to be injected and perceived risk of bleeding. 13. Previous severe hypersensitivity reaction to treatment with Check Point Inhibitor (CPI) or other monoclonal antibody. 14. History of severe immune-related adverse effects (irAEs) for greater than 12 weeks. CPI-related AEs (including irAEs) must have resolved back to Grade 0-1 and patients received no corticosteroids for irAEs for at least two weeks prior to first dose of pembrolizumab in the study. 15. History of interstitial lung disease or prior pneumonitis requiring systemic corticosteroid therapy. In case of uncertainty, a high-resolution computed tomography (HRCT) should be performed at baseline. 16. Patients at high risk of bowel perforation, history of acute diverticulitis, intra-abdominal abscess or abdominal carcinomatosis).

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

Recruiting
Site contact (verified)
Site PIPrincipal Investigator

Leeds Clinical Research Facility

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Site PIPrincipal Investigator

Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Site PIPrincipal Investigator

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Site PIPrincipal Investigator

How to Get in Touch

Chief Medical Officer (CMO)

Sponsor contact

CONTACT

+4178.3060080 T3P1001@t3pharma.com

Head Clinical Operations

Sponsor contact

CONTACT

+4179.355.9741
Data sourced from ClinicalTrials.gov · Last verified: 2026-04