NCT05441956

TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)

A Dose Escalation and Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-326 Monotherapy for the Treatment of Advanced ALK-positive or ROS1-positive Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Shenzhen TargetRx Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, single-arm, open-label, Phase I clinical trial in 3 phases: dose escalation phase, dose expansion phase and indication expansion phase, which will explore the safety, tolerability, PK and preliminary efficacy of TGRX-326 in patients with ALK-positive or ROS1-positive advanced NSCLC.

Detailed description

This is the first-in-human trial with TGRX-326 which aims to evaluate the safety profile and preliminary efficacy profile in patients with ALK-positive or ROS1-positive advanced NSCLC. The primary purpose of this study is to evaluate the safety profile of TGRX-326, including determination of the maximal tolerated dose (MTD) and recommended phase II dose (RP2D), and other safety measures of the investigational drug, such as adverse events and abnormal clinical outcomes. Preliminary efficacy profiles of TGRX-326 is also evaluated according to RECIST Version 1.1. The safety, tolerability and efficacy profiles, along with pharmacokinetic analysis, will be assessed together to determine the optimal dose for expansion.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TGRX-326	Participants are given TGRX-326 tablets orally at one of the dose levels as pre-determined.

Timeline

• Start date: 2021-04-23
• Primary completion: 2025-08-31
• Completion: 2025-10-31
• First posted: 2022-07-01
• Last updated: 2025-05-18

Locations

1 site across 1 country: China