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    DRUG:

    AB-329

    i
    Other names: AB-329, DS1205, DS 1205, DS-1205c, DS 1205b, DS-1205, DS 1205c, DS1205c
    Company:
    Daiichi Sankyo, Nuvation Bio
    Drug class:
    AXL inhibitor
    Related drugs:
    over1year
    Evaluation of combination treatment with DS-1205c, an AXL kinase inhibitor, and osimertinib in metastatic or unresectable EGFR-mutant non-small cell lung cancer: results from a multicenter, open-label phase 1 study. (PubMed, Invest New Drugs)
    DS-1205c was well-tolerated with no new safety signals in patients with advanced EGFR-mutant NSCLC when administered in combination with the EFGR TKI osimertinib. ClinicalTrials.gov ; NCT03255083.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    EGFR (Epidermal growth factor receptor) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • AB-329
    over1year
    Phase 1 study of DS-1205c combined with gefitinib for EGFR mutation-positive non-small cell lung cancer. (PubMed, Cancer Med)
    DS-1205c was generally safe and well tolerated at all dose levels, but the safety profile of ≤800 mg BID was more favorable than 1200 mg BID. The recommended dose for dose-expansion cohorts of DS-1205c in combination therapy with gefitinib was 800 mg BID.
    P1 data • Clinical Trial,Phase I • Journal
    |
    EGFR (Epidermal growth factor receptor) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation
    |
    gefitinib • AB-329
    over3years
    DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=13, Completed, Daiichi Sankyo, Inc. | Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Sep 2020 | Trial primary completion date: Apr 2021 --> Sep 2020
    Clinical • Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
    |
    Tagrisso (osimertinib) • AB-329
    4years
    [VIRTUAL] Phase 1 Study of the AXL Inhibitor DS-1205 in Combination With Osimertinib in Subjects With Metastatic or Unresectable EGFR-Mutant NSCLC (IASLC-WCLC 2020)
    Eligible subjects must either have evidence of radiological disease progression during treatment with erlotinib, gefitinib, or afatinib without the T790M resistance mutation, or must experience disease progression during osimertinib treatment and no risk factors for QTc prolongation. Preliminary analysis of efficacy data reveals that three patients had stable disease beyond 100 days (RECIST v.1.1). Conclusion Dose escalation is ongoing and updated clinical and biomarker data will be presented.
    Clinical • P1 data • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • AXL expression • EGFR T790M negative
    |
    Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • AB-329
    over4years
    [VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with EGFR-mutant NSCLC (ESMO 2020)
    Funding: Daiichi Sankyo. Clinical trial identification: NCT03599518.
    Clinical • P1 data • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • AXL expression • EGFR T790M negative • EGFR mutation + EGFR T790M
    |
    gefitinib • AB-329
    over4years
    DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=21, Completed, Daiichi Sankyo Co., Ltd. | Active, not recruiting --> Completed | N=63 --> 21 | Trial completion date: Mar 2021 --> Jun 2020 | Trial primary completion date: Mar 2021 --> Apr 2020
    Clinical • Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
    |
    gefitinib • AB-329
    over4years
    DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, Daiichi Sankyo, Inc. | Recruiting --> Active, not recruiting | N=21 --> 13
    Clinical • Enrollment closed • Enrollment change • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
    |
    Tagrisso (osimertinib) • AB-329
    over4years
    [VIRTUAL] Phase I study of the AXL inhibitor DS-1205c in combination with osimertinib in subjects with metastatic or unresectable EGFR-mutant non-small cell lung cancer (NSCLC). (ASCO 2020)
    No abstract available
    Clinical • P1 data • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • AXL (AXL Receptor Tyrosine Kinase)
    |
    Tagrisso (osimertinib) • AB-329
    over4years
    [VIRTUAL] A first-in-human phase I study of the AXL inhibitor DS-1205c in combination with gefitinib in subjects with metastatic or unresectable EGFR-mutant NSCLC. (ASCO 2020)
    No abstract available
    Clinical • P1 data • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • AXL (AXL Receptor Tyrosine Kinase)
    |
    gefitinib • AB-329
    over4years
    DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=63, Active, not recruiting, Daiichi Sankyo Co., Ltd. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X
    |
    gefitinib • AB-329