RE: It works.19 Dec 2022 08:04
Here we go, these are the objectives, and we know biopsies are highly likely, make up your own mind.
Primary Objectives:
To evaluate the safety and tolerability of AVA6000.
To determine the maximumtolerated 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 and of active metabolites (doxorubicin and leaving group, ) when given as monotherapy, after a single dose and after multiple dosing. doxorubicinol
To evaluate the initial antitumour 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