drugset / Trial / NCT03130881

Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.

NCT03130881 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-11-08
Primary completion
2020-12-30
Completion
2021-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PLB1003 Unknown — Oral