ALK/ROS1 TKI (3rd generation) · small molecule

deulorlatinib

3 active trials across 2 of our biomarkers, targeting ALK/ROS1. Not approved for any biomarker on marked.bio yet.

Also known as TGRX-326.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ALK fusion 3 3 Phase 3
ROS1 fusion 1 1 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of deulorlatinib.

  1. Shenzhen TargetRx 3

Trials

Status

3 of 3 trials shown

  1. TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 3 Shenzhen TargetRx Started 2023Primary completion 2026-04 NCT06082635

    deulorlatinibcrizotinib FDA EU

    Diagnosed as incurable stage IIIB - IV ALK-positive NSCLC;

    ALK fusionNon Small Cell Lung Cancer

  2. TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)

    Active, not recruiting Phase 2 Shenzhen TargetRx Started 2023Primary completion 2024-12 NCT05955391

    deulorlatinib

    With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous …

    ALK fusionNon-small Cell Lung Cancer

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

    Active, not recruiting Phase 1 Shenzhen TargetRx Started 2021Primary completion 2025-08 NCT05441956

    deulorlatinib

    Diagnosis of ALK-positive or ROS1-positive advanced NSCLC by histopathology or cytology in a Grade-A tertiary hospi…

    ALK fusionROS1 fusionNon-small Cell Lung Cancer