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
Written (signed) Informed Consent.
Male or female ≥ 18 years old.
Life expectancy > 8 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (< 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg with or without anti-hypertensive medication), recent CVA (< 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.
Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.
Absolute neutrophil count (ANC) < 1.5 x 10^9/L
Platelet count < 100 x 10^9/L
Single group
LXP1788 is administered intravenously via Port-A
DrugLXP1788 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.
To determine the MTD and potential phase 2 dose regimen(s) of LXP1788 Injection
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).
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
To assess exposure levels to LXP1788
To assess exposure levels to LXP1788
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)
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LaunXP Biomedical Co., Ltd.
Lead sponsor
Efficient Pharma Management Corp.
Collaborator
