^
    15d
    Deulorlatinib (TGRX-326) in ALK gene fusion positive non-small cell lung cancer after failure of second-generation inhibitors (DRAGON): a single-arm, multicenter, phase 2 trial. (PubMed, J Thorac Oncol)
    Deulorlatinib demonstrated encouraging anti-tumor activity in patients with advanced ALK-positive NSCLC after failure of second-generation ALK inhibitors, including those with the G1202R mutation. Given its favorable safety profile, deulorlatinib represents a promising new option for this population.
    P2 data • Journal
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK fusion • ALK G1202R
    |
    Lorbrena (lorlatinib) • deulorlatinib (TGRX-326)
    12ms
    TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=321, Active, not recruiting, Shenzhen TargetRx, Inc. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Apr 2026
    Enrollment closed • Trial primary completion date
    |
    ALK positive
    |
    Xalkori (crizotinib) • deulorlatinib (TGRX-326)
    12ms
    TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=164, Active, not recruiting, Shenzhen TargetRx, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    ALK positive
    |
    deulorlatinib (TGRX-326)
    1year
    TGRX-326-1004: TGRX-326 Pharmacokinetic Mass Balance (clinicaltrials.gov)
    P1, N=6, Completed, Shenzhen TargetRx, Inc. | Not yet recruiting --> Completed
    Trial completion
    |
    deulorlatinib (TGRX-326)
    over1year
    TGRX-326 Phase I Oral Pharmacokinetic Study (clinicaltrials.gov)
    P1, N=72, Not yet recruiting, Shenzhen TargetRx, Inc.
    New P1 trial
    |
    deulorlatinib (TGRX-326) • TGRX-678
    over1year
    Safety, efficacy and biomarker analysis of deulorlatinib (TGRX-326) in ALK-positive non-small-cell lung cancer: a multicentre, open-label, phase 1/1b trial. (PubMed, J Thorac Oncol)
    Deulorlatinib showed desirable tolerability and efficacy in ALK-positive NSCLC, demonstrating the potential to become a new treatment option in this population.
    P1 data • Journal
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ROS1 positive
    |
    Xalkori (crizotinib) • Lorbrena (lorlatinib) • deulorlatinib (TGRX-326)
    almost2years
    TGRX-326 NSCLC Phase I study: A Phase I Dose Escalation and Dose Expansion 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 (ChiCTR2400081304)
    P1, N=185, Completed, Sun Yat-sen University Cancer Center; Shenzhen TargetRx, Inc.
    New P1 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    deulorlatinib (TGRX-326)
    almost2years
    TGRX-326 Pharmacokinetic Drug Interaction (clinicaltrials.gov)
    P1, N=34, Completed, Shenzhen TargetRx, Inc. | Recruiting --> Completed
    Trial completion
    |
    deulorlatinib (TGRX-326) • itraconazole • efavirenz
    almost2years
    TGRX-326 Pharmacokinetic Mass Balance (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Shenzhen TargetRx, Inc.
    New P1 trial
    |
    deulorlatinib (TGRX-326)
    2years
    TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1, N=198, Active, not recruiting, Shenzhen TargetRx, Inc. | Recruiting --> Active, not recruiting | N=100 --> 198 | Trial completion date: Jun 2024 --> Oct 2025 | Trial primary completion date: Dec 2023 --> Aug 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ROS1 positive
    |
    deulorlatinib (TGRX-326)
    2years
    TGRX-326 Food Effect Pharmacokinetic Study (clinicaltrials.gov)
    P1, N=24, Completed, Shenzhen TargetRx, Inc.
    New P1 trial
    |
    deulorlatinib (TGRX-326)