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
LaunXP Biomedical Co., Ltd.
Lead sponsor
Efficient Pharma Management Corp.
Collaborator