RE: To DE or Not to DE25 Oct 2022 15:44
These are the objectives of phase 1a
Primary objectives:
-Evaluating safety and tolerability
-determine MTD and/or recommended phase 2 dose
Secondary objectives:
- characterise the pharmacokinetics in plasma, urine and tumour of AVA6000, of the pre|CISION 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
So not just safety.
Inflection points have been mentioned several times