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1d
TGRX-326 Phase I Oral Pharmacokinetic Study (clinicaltrials.gov)
P1, N=72, Not yet recruiting, Shenzhen TargetRx, Inc.
New P1 trial
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deulorlatinib (TGRX-326) • TGRX-678
3d
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
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ALK (Anaplastic lymphoma kinase)
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ALK positive • ROS1 positive
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Xalkori (crizotinib) • Lorbrena (lorlatinib) • deulorlatinib (TGRX-326)
5ms
TGRX-326 Pharmacokinetic Drug Interaction (clinicaltrials.gov)
P1, N=34, Completed, Shenzhen TargetRx, Inc. | Recruiting --> Completed
Trial completion
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deulorlatinib (TGRX-326) • itraconazole • efavirenz
6ms
TGRX-326 Pharmacokinetic Mass Balance (clinicaltrials.gov)
P1, N=6, Not yet recruiting, Shenzhen TargetRx, Inc.
New P1 trial
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deulorlatinib (TGRX-326)
8ms
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
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ALK (Anaplastic lymphoma kinase)
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ALK positive • ROS1 positive
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deulorlatinib (TGRX-326)
8ms
TGRX-326 Food Effect Pharmacokinetic Study (clinicaltrials.gov)
P1, N=24, Completed, Shenzhen TargetRx, Inc.
New P1 trial
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deulorlatinib (TGRX-326)
8ms
TGRX-326 Pharmacokinetic Drug Interaction (clinicaltrials.gov)
P1, N=32, Recruiting, Shenzhen TargetRx, Inc. | Not yet recruiting --> Recruiting
Enrollment open
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deulorlatinib (TGRX-326) • itraconazole • efavirenz
9ms
TGRX-326 Drug-Drug Interaction Pharmacokinetic Study (clinicaltrials.gov)
P1, N=32, Not yet recruiting, Shenzhen TargetRx, Inc.
New P1 trial
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deulorlatinib (TGRX-326) • itraconazole • efavirenz
11ms
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P3, N=297, Recruiting, Shenzhen TargetRx, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
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ALK positive
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Xalkori (crizotinib) • deulorlatinib (TGRX-326)
1year
New P3 trial • Metastases
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ALK positive
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Xalkori (crizotinib) • deulorlatinib (TGRX-326)
over1year
New P2 trial
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ALK positive
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deulorlatinib (TGRX-326)
over1year
First-in-human, multicenter phase Ⅰ study of TGRX-326 in patients with advanced ALK-positive non-small cell lung cancer. (ASCO 2023)
Background: TGRX-326, a deuterated derivative of lorlatinib (LOR), is a potent 3rd generation ALK and ROS1 dual TKI with high potency against multiple ALK-resistant mutations...In D-ESCAL and D-EXP, ALK+ pts prior failed on 2nd gen ALK-TKIs or ROS1+ pts resistant to crizotinib (CRZ) were enrolled; in C-EXP, ALK+ pts progression after CRZ (C-EXP-A1),progression after ≥1 2nd gen TKIs (C-EXP A2), ROS1+progression after CRZ (C-EXP-B) and pts with ALK TKI naïve (C-EXP-C) were enrolled... TGRX-326 was well tolerated in pts with advanced ALK+NSCLC and showed promising clinical antitumor activity irrespectively of ALK+ resistance to CRZ and 2nd gen TKIs, especially among those with brain metastases. Impressive activity was seen in ALK TKI naïve NSCLC. TGRX-326 demonstrated antitumor activity against multiple ALK mutations including G1202R.
Clinical • P1 data • Metastases
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ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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ALK positive • ALK mutation • ALK G1202R
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Xalkori (crizotinib) • Lorbrena (lorlatinib) • deulorlatinib (TGRX-326)
almost2years
TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P1, N=100, Recruiting, Shenzhen TargetRx, Inc. | Trial completion date: Mar 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
Trial completion date • Trial primary completion date • Metastases
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ALK (Anaplastic lymphoma kinase)
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ALK positive • ROS1 positive
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deulorlatinib (TGRX-326)
over2years
New P1 trial
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ALK (Anaplastic lymphoma kinase)
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ALK positive • ROS1 positive
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deulorlatinib (TGRX-326)