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    DRUG:

    nazartinib (EGF816)

    i
    Other names: NVS 816, NVS816, EGF816, EGF 816, EGF-816, NVS-816
    Company:
    Novartis
    Drug class:
    EGFR inhibitor
    Related drugs:
    3ms
    Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Tagrisso (osimertinib) • gefitinib • Tabrecta (capmatinib) • nazartinib (EGF816)
    3ms
    Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=227, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons and not due to any safety concerns
    Trial termination
    |
    KRAS (KRAS proto-oncogene GTPase) • DUSP6 (Dual specificity phosphatase 6)
    |
    batoprotafib (TNO155) • nazartinib (EGF816)
    3ms
    Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2025 --> Mar 2026 | Trial primary completion date: Oct 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)
    5ms
    Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=227, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Nov 2025 --> Jul 2025 | Trial completion date: Nov 2025 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • DUSP6 (Dual specificity phosphatase 6)
    |
    batoprotafib (TNO155) • nazartinib (EGF816)
    6ms
    A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=11, Terminated, Massachusetts General Hospital | Active, not recruiting --> Terminated; Slow accrual
    Trial termination
    |
    EGFR mutation • EGFR L858R
    |
    gefitinib • nazartinib (EGF816)
    9ms
    Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)
    9ms
    Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=227, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: May 2025 --> Nov 2025 | Trial primary completion date: May 2025 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    batoprotafib (TNO155) • nazartinib (EGF816)
    1year
    Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2024 --> Apr 2025 | Trial primary completion date: Dec 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)
    over1year
    Characterization of the in vitro metabolic profile of nazartinib in HLMs using UPLC-MS/MS method: In silico metabolic lability and DEREK structural alerts screening using StarDrop software. (PubMed, Heliyon)
    In the context of computational software, making minor adjustments or substituting the dimethylamino-butenoyl moiety throughout the drug design process may increase the metabolic stability and safety properties of new synthesized derivatives. The efficiency of utilizing different in silico software approaches to conserve resources and reduce effort was proved by the outcomes attained from in vitro incubation experiments and the use of NZT in silico software.
    Preclinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    nazartinib (EGF816)
    over1year
    A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=11, Active, not recruiting, Massachusetts General Hospital | Trial completion date: Jun 2024 --> Dec 2024
    Trial completion date
    |
    gefitinib • nazartinib (EGF816)
    over1year
    Capmatinib plus nazartinib in patients with EGFR-mutated non-small cell lung cancer. (PubMed, Eur J Cancer)
    Capmatinib plus nazartinib showed antitumor activity in patients with EGFR-TKI-resistant, EGFR-mutated NSCLC. The overall safety profile was acceptable.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tabrecta (capmatinib) • nazartinib (EGF816)
    over1year
    Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=227, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    batoprotafib (TNO155) • nazartinib (EGF816)