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Advanced Solid TumorPhase 1/2NCT05120596

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

A Phase 1/2 study testing Pembrolizumab+T3P-Y058-739, T3P-Y058-739 (IV) and T3P-Y058-739 (IT) in people with Advanced Solid Tumor, run by T3 Pharmaceuticals AG at 15 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Pembrolizumab+T3P-Y058-739, T3P-Y058-739 (IV) and T3P-Y058-739 (IT)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
15 sitesin 3 countries
Study dates
26 Apr 2022to 15 Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically- or cytologically-proven advanced, unresectable solid tumour for which there is no curative therapy and no alternative therapy is felt to be appropriate.
  • At least one measurable lesion
  • Male or female, 18 years of age or older at the time of signing informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Estimated life expectancy of ≥12 weeks.
  • Resolution of all acute reversible toxic effects of prior therapy or surgical procedure to baseline or Grade ≤1 (except alopecia).
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  • Adequate iron stores without significant iron overload
  • Adequate organ function
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
  • 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).

Who cannot join

  • 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.
  • Known central nervous system (CNS) metastases.
  • 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.
  • 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.
  • 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).
  • 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).
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  • 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.
  • 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.
  • Patients who are allergic to chloramphenicol or to all of the following antibiotics: co-trimoxazole, doxycycline, ceftriaxone and cefotaxime.
  • History of hypersensitivity to desferrioxamine
  • 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.
  • 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.
  • Previous severe hypersensitivity reaction to treatment with Check Point Inhibitor (CPI) or other monoclonal antibody.
  • 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.
  • 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.
  • Patients at high risk of bowel perforation, history of acute diverticulitis, intra-abdominal abscess or abdominal carcinomatosis).

Trial locations and contacts

15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Chief Medical Officer (CMO) contact

+4178.3060080

T3P1001@t3pharma.com

Head Clinical Operations contact

+4179.355.9741

15 sites in 3 countries

Spain8 sites, 8 recruiting

  • Vall d'Hebron Institute of Oncology

    Barcelona, 08035

    Site PI

    Recruiting

  • Institut Catala D'oncologia

    L'Hospitalet de Llobregat, 08908

    Site PI

    Recruiting

  • Clinica Universidad de Navarra

    Madrid, 28027

    Site PI

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Site PI

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Site PI

    Recruiting

  • START Madrid-CIOCC Hospital Univ. HM Sanchinarro

    Madrid, 28050

    Site PI

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Site PI

    Recruiting

  • Hospital Clínico Universitario de Valencia (INCLIVA)

    Valencia, 46010

    Site PI

    Recruiting

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • Cancer Research UK Clinical trials; Unit Partner in CaCTUS- Cancer clinical trials Unit Scotland; Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Site PI

    Recruiting

  • Leeds Clinical Research Facility

    Leeds, LS9 7TF

    Site PI

    Recruiting

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Site PI

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

    Site PI

    Recruiting

Other trials in United Kingdom

Switzerland3 sites, 3 recruiting

  • University Hospital Bern (Inselspital)

    Bern, 3010

    Site PI

    Recruiting

  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

    Lausanne, 1011

    Site PI

    Recruiting

  • University Hospital of Zürich (Universitätsspital Zürich)

    Zurich, 8091

    Site PI

    Recruiting

Other trials in Switzerland

About this study

Official title: An Open-label, Phase I/II Study of T3P-Y058-739, a Genetically-modified Strain of the Bacterium Yersinia Enterocolitica, in Patients With Advanced Solid Tumours

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.

Read the detailed description

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.

Being tested
Pembrolizumab+T3P-Y058-739, T3P-Y058-739 (IV), T3P-Y058-739 (IT)
Keywords
Advanced, Solid, Tumor, Cancer, Oncology, Genetically, Bacterium, gene
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab+T3P-Y058-739Drug

    intravenous infusion or intratumoural injection

  • T3P-Y058-739 (IV)Drug

    Intravenous infusion

  • T3P-Y058-739 (IT)Drug

    Intratumoral use

Study groups in NCT05120596
Study groupRoleWhat they receive
T3P-Y058-739 Intravenous (IV)ExperimentalIntravenous infusion
Receives: Drug: T3P-Y058-739 (IV)
T3P-Y058-739 Intratumoural (IT)ExperimentalIntratumoural injection
Receives: Drug: T3P-Y058-739 (IT)
T3P-Y058-739 plus pembrolizumabExperimentalIntravenous infusion
Receives: Drug: Pembrolizumab+T3P-Y058-739

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: To assess the safety and determine the recommended phase II dose (RP2D) when given by IT injection and by IV infusion, as monotherapy and in combination with pembrolizumab.

    AEs(adverse events), SAEs(serious adverse events) will be graded by the investigator according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE Version 5.0).

    Measured: up to 45 months

  2. Phase 2: To assess the safety and preliminary antitumor response T3P when given by IT injection and/or IV infusion, as monotherapy and in combination with pembrolizumab.

    Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) (Seymour et al, 2017).

    Measured: up to 45 months

Secondary outcomes (6)

  1. Assessment of Duration of response (DoR)

    DoR and PFS according to RECIST 1.1 (Eisenhauer et al, 2009) or modified criteria for selected malignancies, as appropriate(e.g., Verslype et al, 2012 for hepatocellular carcinoma).

    Measured: up to 45 months

  2. Assessment of progression free survival (PFS)

    PFS according to RECIST 1.1 (Eisenhauer et al, 2009) or modified criteria for selected malignancies, as appropriate(e.g., Verslype et al, 2012 for hepatocellular carcinoma).

    Measured: up to 45 months

  3. To evaluate the distribution of T3P

    Microbiological culture and/or quantitative polymerase chain reaction (qPCR) of samples of blood, urine, stool and (in patients with tumor's close to or involving the oropharynx) saliva.

    Measured: up to 45 months

  4. To evaluate the clearance of T3P

    Shedding will also be evaluated in swabs taken from lesions that ulcerate following T3P administration.

    Measured: up to 45 months

  5. To evaluate the shedding of T3P

    Tumor colonisation will also be evaluated in tumor biopsies (optional).

    Measured: up to 45 months

  6. Assessment of Overall survival (OS)

    Overall survival (OS) (maximum 16 months of follow-up).

    Measured: Maximum 16 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2021
  2. Study start26 Apr 2022
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion15 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
dose-finding, safety, and proof-of-concept study
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05120596
Sponsor's protocol ID
T3P1001
Status last verified
Apr 2026
First submitted
14 Sep 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab+T3P-Y058-739, T3P-Y058-739 (IV) and T3P-Y058-739 (IT) in people with Advanced Solid Tumor, run by T3 Pharmaceuticals AG at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, United Kingdom, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chief Medical Officer (CMO) (+4178.3060080, T3P1001@t3pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: To assess the safety and determine the recommended phase II dose (RP2D) when given by IT injection and by IV infusion, as monotherapy and in combination with pembrolizumab. (time frame: up to 45 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05120596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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