A long term follow up study of ATX-101 given by intravenous infusion once every week in patients with advanced solid tumours.

ATX-101 treatment will be administered weekly in cycles of 21-day duration, with a single IV infusion. All patients will receive the below listed mandated premedications prior to each ATX101 infusion. Paracetamol, corticosteroid, H1 and H2 inhibitors are to be administered within 60 to 90 minutes prior to infusion start. • Dexamethasone 12 mg IV (or pharmacologically alternative corticosteroid at an equivalent dose) • An oral antihistamine of the 2nd generation, e.g. cetirizine, fexofenadine, or loratadine • Ranitidine 50 mg IV (or pharmacologically alternative antihistamine H2 antagonist at recommended dose) OR Ranitidine 150 mg orally OR Famotidine 20 mg orally • Acetaminophen 1 g oral or rectal Montelukast (anti-leucotriene) may be administered at the discretion of the investigator, the night prior to each infusion. Dosing to occur on Day 1, 8 and 15 (± 3 days) of each cycle for up to 12 months. treatment with ATX-101 the subject will be allowed to escalate to the highest tolerated ATX-101 dose level determined from the AM ATX101-01 study. Subjects will receive 4 cycles of treatment (i.e. 4 x 21 days = 3 months), then, at the completion of each 4 cycles of treatment (i.e. every 3 months ± 14 days), in addition to all other specified safety evaluations, radiographic (MRI/CT) assessments will be conducted per RECIST V1.1 to evaluate the subject’s ongoing response to long-term treatment, disease status and to determine if dosing per individual subject should continue for the next 4 cycles of treatment, up to a maximum total of 12 months treatment. Treatment exposure, including duration of treatment and extent of exposure to study drug, will be summarised, for all subjects overall. Total treatment exposure across both AM ATX101-01 and the long term follow up component (AM ATX101-02) will be assessed.