Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1001 in Patients With Met-positive (Met+) Advanced Non-small Cell Lung Cancer (NSCLC)
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.
This is a Phase I, open-label, multicentre study of PB1001 administered orally to patients
with Met-positive (Met+) advanced NSCLC. The study includes a Dose-escalation Part (part
A)and a Dose Expansion Part(part B). The aim of the part A is to estimate the MTD and to
identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1001
single agent as well as to determine the PK/PD profile .Once response has been observed in
certain dose level ,then followed by the expansion part to further assess the clinical
efficacy and safety of PLB1001 single agent. Aprox. 40 patients will be enrolled in PART A,
while 20-30 patients for expansion cohort .
PLB1001 is a potent selective c-Met inhibitor. PLB1001 acts on cancer by blocking abnormal
cmet-mediated signalling, leading to profound tumour growth inhibition in xenografts of
non-small cell lung cancer (NSCLC) tumours. Preliminary data from a c-Met inhibitor INC 280
has provided possibility on the safety and clinical activity of PLB1001 monotherapy in this
patient population.
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