NCT05955391

Brief Summary

This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

July 10, 2023

Last Update Submit

May 16, 2025

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    ORR defined by the ratio of patients who reachedthe treatment response; ORR as evaluated by independed review committee (IRC)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

Secondary Outcomes (12)

  • Disease Control Rate (DCR)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

  • Duration of Response (DOR)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

  • Time to Response (TTR)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

  • Progression Free Survival (PFS)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

  • Intracranial Objective Response Rate (IC-ORR)

    Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

  • +7 more secondary outcomes

Other Outcomes (1)

  • Plasma Cmax

    Day 1 of Cycle 1, 3, 5, 7, and every 2 cycles until cycle 17 (each cycle is 21 days)

Study Arms (1)

Experimental: TGRX-326

EXPERIMENTAL

Subjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles.

Drug: TGRX-326

Interventions

TGRX-326DRUG

Subjects will be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles

Experimental: TGRX-326

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed;
  • ≥ 18 years of age on the day of ICF signing, regardless of gender.
  • With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;
  • Providing prior ALK positive test results at screening;
  • Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;
  • Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors;
  • At least one measurable lesion;
  • An ECOG PS score within 0-2;
  • Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;
  • Expected survival ≥ 3 months;
  • Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after administration of the investigational drug. Women of reproductive age include women before menopause and within 2 years after menopause. Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.

You may not qualify if:

  • Previous use of any third-generation ALK inhibitors other than TGRX-326;
  • Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator;
  • Having another type of cancer except for lung cancer;
  • Major surgery within 4 weeks prior to the first dose;
  • Spinal cord compression caused by tumor, unless the subject achieves significant pain control and full recovery of neurological function within 4 weeks prior to the first dose.
  • Abnormal gastrointestinal function that affect absorption within the past 6 months;
  • History of active pneumonia or clinically significant interstitial pneumonia, or radiation or drug-induced lung disorder with treatment needs;
  • Cardiac insufficiency;
  • Abnormal and clinically significant QTc on ECG or need of concomitant use of any drug known to prolong QT interval and cause torsades de pointes;
  • Uncontrolled hypertension after drug treatment;
  • Uncontrolled hyperglycaemia, acute attack of cholelithiasis, and susceptibility to acute pancreatitis;
  • Severe or uncontrolled systemic diseases causing expected intolerance to the investigational drug as judged by the investigator;
  • Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation and/or ventricular tachycardia;
  • Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug;
  • Toxic reactions associated with prior surgery and prior antineoplastic therapies that have not recovered and may affect the subject safety as assessed by the investigator.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Li Zhang, MD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 21, 2023

Study Start

January 18, 2023

Primary Completion

December 29, 2024

Study Completion

December 31, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)