Actively Recruiting
First in Human Study of T3P-Y058-739 (T3P)
Led by T3 Pharmaceuticals AG · Updated on 2026-04-13
100
Participants Needed
15
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First in Human Study of T3P-Y058-739 (T3P)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with histologically or cytologically confirmed advanced, unresectable solid tumor with no curative or appropriate alternative therapy
- At least one measurable tumor lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 12 weeks or more
- Recovery to baseline or Grade 1 or less of any acute toxic effects from prior therapy or surgery (except hair loss)
- Adequate iron stores without significant iron overload
- Adequate organ function
- Ability to provide signed informed consent and comply with study requirements
- At least one lesion measurable by iRECIST/RECIST 1.1 and suitable for direct intratumoral injection, visible, palpable, or detectable by ultrasound and accessible for injection
You will not qualify if you...
- Current or prior malignancy that could affect study compliance or result interpretation, except certain treated skin cancers or carcinoma in situ
- Known central nervous system metastases
- Prior allogeneic bone marrow or stem cell transplant, immunodeficiency, or current immunosuppressive therapy including systemic corticosteroids
- Active uncontrolled infection or positive for HIV, hepatitis B or C
- Recent major infection without recovery to baseline
- Recent or current Yersinia infection or detectable Yersinia enterocolitica in stool
- Recent antibiotic use that could affect bacterial viability
- Known cardiac valvular disease, arterial aneurysms, artificial heart valves, or other non-removable prostheses
- History of bacterial endocarditis
- Significant autoimmune conditions or major cardiac issues requiring regular medication
- Allergy to chloramphenicol or listed antibiotics
- Hypersensitivity to desferrioxamine
- Other severe medical or psychiatric conditions increasing risk or interfering with results
- Bleeding disorders or use of therapeutic anticoagulants unless low bleeding risk
- Severe hypersensitivity to checkpoint inhibitors or monoclonal antibodies
- History of severe immune-related adverse events unresolved for more than 12 weeks
- History of interstitial lung disease or pneumonitis requiring steroid therapy
- High risk of bowel perforation or related abdominal conditions such as acute diverticulitis or abscess
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
2
Vall d'Hebron Institute of Oncology
Barcelona, Spain, 08035
Actively Recruiting
3
Institut Catala D'oncologia
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
4
Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
5
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
6
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
7
START Madrid-CIOCC Hospital Univ. HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
8
Hospital Clínico Universitario de Valencia (INCLIVA)
Valencia, Spain, 46010
Actively Recruiting
9
University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Actively Recruiting
10
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
Lausanne, Switzerland, 1011
Actively Recruiting
11
University Hospital of Zürich (Universitätsspital Zürich)
Zurich, Switzerland, 8091
Actively Recruiting
12
Cancer Research UK Clinical trials; Unit Partner in CaCTUS- Cancer clinical trials Unit Scotland; Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
13
Leeds Clinical Research Facility
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
14
Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
15
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
C
Chief Medical Officer (CMO)
CONTACT
H
Head Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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