Brief Summary
This is a Phase I, open-label, single arm, safety and tolerability study which will evaluate escalating dosethe amount of medication taken cohorts of ATX-101 to determine the maximum tolerated dose in subjects with advancedat a late stage, far along solid tumours.
Intervention/Treatment
- Drug: ATX-101
Inclusion Criteria
- Advanced disease (solid tumoura tissue mass that forms from groups of unhealthy cells) for which conventional anti-tumour treatment has been exhausted or has been refused.
- Measurable or non-measurable (but radiologically evaluable) disease on CT/MRI scan with at least one lesion outside previously irradiated areas.
- Have an ECOG Performance status 0-2.
- Life expectancy of at least 3 months.
- Meet the following laboratory requirements:
- Absolute lymphocyte count greater than or equal 0.8 x 109/L.
- Platelet count greater than or equal 75 x 109/L.
- Activated partial thromboplastin time (aPTT)/prothrombin time (PT) less than or equal to 1.5 x the upper limit of normal (ULN).
- Total bilirubin level less than or equal to 1.5 x ULN.
- Aspartate transaminase (AST) and Alanine Aminotransferase (ALT) less than or equal to 2.5 x ULN (less than or equal to 5 x ULN if liver metastasiswhen the cancer has spread to other parts of the body, also known as mets present).
- Creatinine less than or equal to 1.5 x ULN.
- Albumin greater than or equal to 30 g/L.