Spots Global Cancer Trial Database for Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

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Trial Identification

Brief Title: Assessing the Safety and Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Official Title: A Phase I, Open-label, Multicenter, Dose Escalation and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of PLB1004 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study ID: NCT05347628

Conditions

Non-Small-Cell Lung Cancer

Interventions

PLB1004

Study Description

Brief Summary: This is a phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PLB1004, and to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase II dose (RP2D).

Detailed Description: The study includes a Dose-escalation Part and a Dose Expansion Part. The aim of the Dose-escalation Part is to estimate the MTD (if possible), identify the DLT (if possible) and the RP2D for PLB1004. The Dose Expansion Part is to further assess the clinical efficacy and safety of PLB1004.