ONCOS-102 (Previously CGTG-102) for Therapy of Advanced Cancers

Inclusion Criteria

• Solid tumour refractory to evidence-based oncological therapies.
• Age 18 years and over.
• At least one tumour mass measurable by PET (i.e. PET-positive lesion that can reliably be assessed for SUVmax, typically featuring longest diameter ≥2 cm).
• Tumour is injectable i.t. by direct visualisation/palpation or by imaging-guidance (ultrasound). I.t. includes intracavitary injections, particularly intraperitoneal and intrapleural.
• Histological confirmation of primary disease or relapse.
• Patient has given signed informed consent.
• WHO performance score 0-1 and life expectancy more than 3 months.
• Previous anti-cancer treatment at least 1 month before Day 1.
• Tumour assessed to be suitable for biopsy.
• Hepatic, renal and bone marrow functions within normal limits for the target population as indicated by the following:
• Total bilirubin ≤ the upper limit of normal (ULN).
• ASAT, ALAT ≤3.0 × ULN.
• Serum creatinine ≤1.5 x ULN.
• International normalised ratio (INR) ≤1.5 x ULN.
• Haematologic parameters: Patients can be transfused to meet the haemoglobin and platelet count entry criteria.
• Haemoglobin ≥10 g/dL
• Leucocytes ≥2.3 x 109/L
• Platelet count ≥7.5 x 109/L

Exclusion Criteria

• Use of high dose systemic immune suppressive medication within 3 weeks of anticipated first treatment. Note: patients taking low-dose corticosteroids for the treatment of nausea and/or taking maintenance corticosteroids are permitted to enrol.
• Known infection with HIV or known underlying genetic immunodeficiency disease as these might affect the safety and efficacy of treatment.
• Treatment of the injected tumour(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks prior to the first treatment.
• Recent thromboembolic event (deep venous thrombosis, pulmonary embolism).
• Clinically significant active infection or clinically significant medical condition considered high risk for investigational new drug treatment (e.g. pulmonary, neurological, cardiovascular, metabolic, clinically significant and/or rapidly accumulating pericardial effusion).
• Severe or unstable cardiac disease.
• Known brain metastases, glioma. Central nervous system malignancy, including carcinomatosis meningitis.
• Pulse oximetry oxygen saturation <90% at rest in room air.
• Vaccination with a live virus (i.e. measles, mumps, rubella, etc.) <30 days prior to the first treatment.
• History of hepatic dysfunction, cirrhosis or hepatitis.
• Prior organ transplant.
• Pregnant or lactating patients.
• Evidence of coagulation disorder.
• Other conditions which, in the opinion of the investigator, might interfere with the study findings or represent a safety hazard for the patient.