Clinical Drug Experience Knowledgebase

Criteria

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.