NCT05347628

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

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)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Avistone Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small-Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PLB1004	PLB1004 is a capsule in the form of 10mg and 40mg.

Timeline

• Start date: 2020-08-25
• Primary completion: 2023-04-04
• Completion: 2024-11-30
• First posted: 2022-04-26
• Last updated: 2023-08-21

Locations

1 site across 1 country: China