A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor. Patients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected. The main questions it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection 2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
LXP1788 Injection is formulated as a solution for injection and will be administered intravenously for 60 minutes on days 1, 8, 15, 22 of the cycle. Each cycle will be 28 days.
China Medical University Hospital
Taichung, Taiwan
RECRUITINGNational Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGTo determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection
Time frame: 2 years
To characterize the plasma PK profile of LXP1788 following IV administration of LXP1788 Injection
PK blood samples to determine plasma concentrations of LXP1788 will be collected at the time points listed in the schedule of events table. Where possible, the plasma concentration-time data will be used to calculate the following parameters for LXP1788 Injection by non-compartmental methods: Maximum plasma concentration (Cmax), dose-normalized Cmax (Cmax/D), area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24), dose-normalized AUC0-24 (AUC0-24/D), AUC from time 0 to the last quantifiable concentration (AUC0-last), dose-normalized AUC0-last (AUC0-last/D), AUC from time 0 extrapolated to infinity (AUC0-inf), dose-normalized AUC0-inf (AUC0-inf/D), time to Cmax (tmax), plasma clearance (CL), volume of distribution (Vz), terminal rate constant (λz), and terminal elimination half-life (t1/2).
Time frame: 2 years
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
To assess the safety, tolerability, and dose-limiting toxicity (DLT) of LXP1788 Injection
Time frame: 2 years
To assess exposure levels to LXP1788
To assess exposure levels to LXP1788
Time frame: 2 years
To assess anti-tumor activity of LXP1788 Injection
To assess anti-tumor activity of LXP1788 Injection * Objective response rate (ORR) using RECIST 1.1 for solid tumor * Time to tumor progression (TTP) * Disease control rate (DCR) * Clinical benefit rate (CBR) * Duration of response (DoR) * Progression free survival (PFS)
Time frame: 2 years
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