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

NCT05441956 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TGRX-326

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

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Shenzhen TargetRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441956 on ClinicalTrials.gov