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 PLB1003 in Patients With ALK-positive (ALK+) 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 PLB1003.
This is a Phase I, open-label study of PB1003 administered orally to patients with
ALK-positive (ALK+) 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 PLB1003 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 PLB1003 single agent. Aprox 40 patients will be enrolled in PART A, while 12-24
patients for expansion cohort .
PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal
ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of
non-small cell lung cancer (NSCLC) tumours.
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