BacTRL-IL-12-1: This phase I trial is assessing the safety, tolerability and effectiveness of a novel bacterial therapy (bacTRL-IL-12) to treat advanced solid tumours that have not responded to treatmentA Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours

Exclusion

1. Presence or history of brain metastases or abscess;

2. Presence of known or suspected ongoing ischemia of non-tumor tissues that may be inadvertently colonized by bacteria including:

   • Ischemic peripheral vascular disease, myocardial infarction within the past 6 months;
   • Congestive heart failure > class II New York Heart Association;
   • Unstable angina (anginal symptoms at rest) or new onset angina (commenced within the last 3 months);
   • Patent foramen ovale;
   • Prior history or current bacterial endocarditis,
   • Existing thrombus (either arterial or venous) as well as known history of deep vein thrombosis, permanent pacemakers, automated implantable cardioverter-defibrillators, left ventricular assist devices, or other intravascular cardiac device, known arteriovenous malformations;
   • Cerebrovascular event, including transient ischemic attacks within the past 6 months;
3. An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices) that could allow inadvertent bacterial colonization;
4. Abnormal fluid collections (e.g. ascites and/or pericardial and/or pleural effusions) that could allow inadvertent bacterial colonization;
5. Has tumor masses immediately adjacent to, and/or with infiltration into, large arteries, veins or vessels;
6. Bacteremia and/or abscess and/or treatment with systemic (oral or IV) antibiotics within 4 weeks prior to dosing;
7. Anticipated exposure to systemic antibiotics within 4 weeks of dosing;
8. Positive for human immunodeficiency virus, hepatitis B or hepatitis C at screening;
9. Treatment with radiation therapy to a visceral organ or tumors within 2 weeks prior to dosing;
10. Treatment with any programmed cell death protein-1 and/or programmed cell death ligand 1 inhibiting agent within 2 weeks prior to dosing;
11. Treatment with any investigational agent for treatment of cancer or related comorbidity within 4 weeks prior to dosing;
12. Treatment with any chemotherapy or major surgery within 6 weeks prior to dosing;
13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) or other agents used in study;
14. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disorder, or psychiatric illness/social situations that would limit compliance with study requirements;
15. Any other reason that, in the opinion of the investigator and/or sponsor, precludes the subject from participating in the trial.