This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1.
Linear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGAdverse events (AEs)
Incidence of treatment-related AEs
Time frame: 8 weeks
Maximum tolerated dose (MTD)
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Time frame: 4 weeks
Phase II dose (RP2D)
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
Time frame: 4 weeks
Tmax
Time to maximum plasma concentration
Time frame: Approximately 4 weeks
Cmax
Time to maximum plasma concentration
Time frame: Approximately 4 weeks
AUC
Area under the time-concentration curve
Time frame: Approximately 4 weeks
t1/2
Observed terminal half-life
Time frame: Approximately 4 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: 12 months (anticipated)
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