RE: Elliot wave14 Feb 2023 09:14
Primary Objectives:
• To evaluate the safety and tolerability of AVA6000.
• To determine the maximum-tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) for the dose expansion phase.
Secondary Objectives:
• To characterise the pharmacokinetics (PK) in plasma, urine and tumour of AVA6000, of the preCISION leaving group, and of active metabolites (doxorubicin and doxorubicinol) when given as monotherapy, after a single dose and after multiple dosing.
• To evaluate the initial anti-tumour activity of AVA6000 according to RECIST.1.1 criteria (overall response rate [ORR], duration of response [DoR], disease control rate [DCR] progression free survival [PFS ] and overall survival).