Advanced solid tumors Cancer Refractory cancer
Conditions
Interventions
Personalized treatment with oncolytic viruses where the virus type, dose, dosing regimen, virus sensitizers, combination therapies and route of injection is optimized for each individual
Sponsors
Oncos Therapeutics Ltd (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Solid tumor cancer progressing after available routine therapies
Exclusion criteria
Exclusion criteria: 1. Known brain metastases 2. Recent thromboembolic event 3. Clinically significant active infection 4. Clinically significant medical condition considered high risk for experimental therapy (e.g. pulmonary, neurological, cardiovascular) 5. Severe or unstable cardiac disease 6. History of hepatic dysfunction 7. Cirrhosis or hepatitis 8. Women who are pregnant or nursing an infant 9. Previous organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Timepoints: Measured at baseline and at 3 months. However there is certain variability since each patient treatment is personalized and follow-up may be adjusted accordingly. 2. Methods: 2.1. RECIST 1.1 2.2. Modified PET Response Criteria in Solid Tumors 2.3. Applicable tumor markers from serum, depending on cancer type 2.4. Overall survival as days from first treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety 2. Adverse events 3. Overall Survival 4. Progression Free Survival 5. Imaging (PET, CT, MRI) based responses 6. Tumor marker responses 7. Symptomatic responses 8. Quality of life 9. Correlative biological data | — |
Countries
Finland
Outcome results
None listed