FIH Study to Evaluate Safety, Tolerability, PK, PD & Preliminary Efficacy of AT03-65 With Advanced Solid Tumors
brief summary
A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AT03-65 in Adults with Advanced Solid Tumors
detailed description
This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AT03-65 in adults with advanced solid tumors. AT03-65 is administered via intravenous infusion using an accelerated escalation method for the lower 3 dose level groups and the 3 + 3 escalation method is used in the subsequent dose level groups.
The study design is to identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) during 21-day cycle. One or more doses or regimens lower than or at the MTD may be selected for further evaluations under Dose Expansion to further evaluate the IMP and identify the RP2D.
official title
A Phase I, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AT03-65 in Adults With Advanced Solid Tumors