Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours

Exclusion Criteria

• •Medical Conditions
• •1. The potential participant is deemed to be a candidate for hepatic surgery or locoregional therapy for liver lesions with curative intent or requires other systemic anti-cancer therapy.
• •2. The participant has clinically significant ascites (Grade ≥2).
• •3. Participants with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the participant to cooperate and participate in the trial; other examples of such conditions would include unstable or uncontrolled hypertension, unstable angina, myocardial infarction or cerebrovascular accident within 6 months of study entry.
• •4. The participant requires continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 4 weeks prior to the first dose of study treatment. Single doses of corticosteroids for prophylaxis of allergic reactions during imaging studies with contrast are allowed within 4 weeks of study treatment.
• •5. The participant has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that require general anesthesia must have been completed at least 2 weeks before first dose of IVX037.
• •6. Participants with bleeding diathesis due to underlying medical conditions or the use of anticoagulation medications that is unable to be reversed by medical treatment.
• •7. Participants with tumors that lie close to an airway, major blood vessel or spinal cord, which, in the opinion of the Investigator, could cause occlusion, compression, or erosion of the vital structures.
• •8. Participants with multi-focal miliary disease without critical target lesions. Prior/Concomitant Therapy
• •9. Participants who have been previously treated with an immune checkpoint inhibitor (e.g., an anti-CTLA-4, anti-PD-1 or anti-PD-L1) must have completed their last dose at least 28 days prior to Day 1 and have demonstrated progressive disease during or following the immune checkpoint inhibitor therapy. The participant must also have no medical history of immune mediated adverse events including infusion (hypersensitivity) reactions ≥ Grade 3 (CTCAE), with the exceptions of adequately treated hypothyroidism and type 1 diabetes mellitus (hyperglycemia) resulting from past treatment with an immune checkpoint inhibitor and non-exfoliative dermatologic reactions such as vitiligo. A history of Grade 2 immune-mediated infusion reactions to an immune checkpoint inhibitor while receiving adequate prophylactic treatment for hypersensitivity reactions is also exclusionary.
• •10. Participants who require prohibited treatments (i.e., non-protocol-specified anticancer pharmacotherapy, surgery, or radiotherapy for treatment of malignancy). Prohibited medications must be ceased at least 21 days or 5 half-lives (whichever is longer) prior to Day 1.
• •Prior/Concurrent Clinical Study Experience
• •11. Is currently participating and receiving other study therapy including an investigational agent or device within 4 weeks of Day 1.
• •12. Participants who have received a live vaccine within 4 weeks of the first day of planned IVX037 treatment or any other vaccine including killed virus and mRNA vaccines within 2 weeks of the first day of planned IVX037 treatment.
• •Diagnostic Assessments
• •13. Participant with active (i.e., symptomatic or growing) central nervous system (CNS) metastases. Participants with CNS metastases are eligible for the trial if the metastases have been treated by surgery and/or radiotherapy, the participant is off corticosteroids for at least 2 weeks prior to first dose of IVX037 and have stable disease on imaging for 3 months prior to Day 1.
• •14. Participant has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by the local health authority.
• •15. Participant has a severe infection or other uncontrolled active infectious disease requiring treatment that would interfere with the evaluation of safety and efficacy or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
• •16. Has a history of other malignancies within the previous 3 years, except for locally curable cancers which have been apparently cured such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast or other cancers with low risk of recurrence in discussion with the Sponsor.
• •17. Has a history of drug-induced interstitial lung disease or non-infectious pneumonitis requiring steroids, except for those induced by radiation therapies.
• •18. Has a history of a prior organ transplantation, including allogenic stem-cell transplantation.
• •19. Has an active or known documented autoimmune disease within the past 2 years that has required systemic treatment.
• •20. Has a history of primary immunodeficiency.
• •21. Has an evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, or recent hospitalization for small bowel obstruction within 3 months prior to starting trial treatment.
• •22. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
• •Other Exclusions
• •23. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 120 days after the last dose of trial treatment.