RE: The Leaving Group11 Jan 2023 14:21
The presentation certainly says we will get info on efficacy.
Q3/4 2022
• AVA6000 Phase I dose escalation data
• Biopsy data: AVA6000, Doxorubicin & FAP
•Modelled pK Doxorubicin data
• MTD (if reached)/RP2D selected.
Primary Objectives:
• To evaluate the safety and tolerability of AVA6000.
• To determine the maximum-tolerated dose (MTD) (if one is reached) 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).
https://avacta.com/wp-content/uploads/2022/06/AGM-Update-2022_.pdf