Glioma Clinical Trial
Official title:
A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas
This phase I, open-label, 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 single and multiple doses of PLB1001 in Patients with PTPRZ1-MET fusion gene positive recurrent high-grade Gliomas.
This is a Phase I, open-label study of PLB1001 administered orally to patients with
PTPRZ1-MET fusion gene positive recurrent high-grade Gliomas. The aim of dose-escalation
study is to estimate the MTD and to identify the dose-limiting toxicity(DLT) and the
recommended phase II dose (RP2D) for PLB1001 single agent as well as to determine the PK/PD
profile. Aprox. 20 patients will be enrolled in this study.
PLB1001 is a potent selective c-Met inhibitor. PLB1001 acts on cancer by blocking abnormal
cMET-mediated signaling (including PTPRZ1-MET fusion gene), leading to profound tumor growth
inhibition in xenografts of PTPRZ1-MET fusion gene positive glioblastoma tumor.
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