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    DRUG:

    ELVN-002

    i
    Other names: ELVN-002
    Associations

    News

    Trials
    Company:
    Enliven Therapeutics
    Drug class:
    HER2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    8ms
    ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer (clinicaltrials.gov)
    P1, N=255, Recruiting, Enliven Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Herceptin (trastuzumab) • paclitaxel • 5-fluorouracil • capecitabine • oxaliplatin • Halaven (eribulin mesylate) • leucovorin calcium • ELVN-002
    8ms
    ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer (clinicaltrials.gov)
    P1, N=255, Not yet recruiting, Enliven Therapeutics
    New P1 trial • Metastases
    |
    Herceptin (trastuzumab) • paclitaxel • 5-fluorouracil • capecitabine • oxaliplatin • Halaven (eribulin mesylate) • leucovorin calcium • ELVN-002
    10ms
    ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=178, Recruiting, Enliven Therapeutics | Phase classification: P1a/1b --> P1
    Phase classification
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • BRAF V600E • HER-2 amplification • BRAF V600 • ALK mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
    1year
    A Study of ELVN-002 in Healthy Adult Volunteers: Part A (ACTRN12623000440628)
    P1, N=48, Not yet recruiting, Enliven Therapeutics, Inc.
    New P1 trial
    |
    ELVN-002
    1year
    A Study of ELVN-002 in Healthy Adult Volunteers: Part B (ACTRN12623000431628)
    P1, N=6, Not yet recruiting, Enliven Therapeutics, Inc.
    New P1 trial
    |
    ELVN-002
    1year
    A Study of ELVN-002 in Healthy Adult Volunteers: Part C (ACTRN12623000652673)
    P1, N=24, Recruiting, Enliven Therapeutics, Inc. | Initiation date: May 2000 --> May 2023
    Trial initiation date
    |
    itraconazole • ELVN-002
    1year
    A Study of ELVN-002 in Healthy Adult Volunteers: Part C (ACTRN12623000652673)
    P1, N=24, Recruiting, Enliven Therapeutics, Inc.
    New P1 trial
    |
    itraconazole • ELVN-002
    over1year
    Phase 1a/b Study of ELVN-002, In Solid Tumors with HER2 Mutations, Amplification or Overexpression (IASLC-WCLC 2023)
    Additionally, ELVN-002 in combination with ado-trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd) exhibited increased anti-tumor activity in vivo compared to either drug alone.Non-clinical data suggests ELVN-002 has a favorable pharmacokinetic (PK) profile and low risk of QTc prolongation. Sponsor: Enliven Therapeutics. NCT0565087
    P1 data • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 YVMA
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
    over1year
    Trials in Progress: Phase 1a/b study of ELVN-002, in Solid Tumors with HER2 Mutations, Amplification or Overexpression (IASLC-WCLC 2023)
    Additionally, ELVN-002 in combination with ado-trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd) exhibited increased anti-tumor activity in vivo compared to either drug alone.Non-clinical data suggests ELVN-002 has a favorable pharmacokinetic (PK) profile and low risk of QTc prolongation. The trial opened for enrollment in February 2023.Study sponsor: Enliven Therapeutics. NCT0565087
    P1 data • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 YVMA
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
    over1year
    Preclinical Activity of ELVN-002: A Potent, Selective, Irreversible and CNS Penetrant HER2 and pan-HER2 Mutant Small-Molecule Inhibitor for the Treatment of HER2-Driven Malignancies (AACR 2023)
    Enhertu (T-DXd), a HER2-specific antibody-drug conjugate was recently approved as an important therapy for this patient population...Currently, tucatinib is the only HER2-selective small molecule inhibitor approved for metastatic breast cancer in combination with trastuzumab and capecitabine...Additionally, ELVN-002 could provide a meaningful therapeutic option for patients with CNS metastases. ELVN-002 has been selected for clinical development.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR mutation • HER-2 amplification • HER-2 mutation • HER-2 expression • EGFR wild-type • HER-2 exon 20 mutation • HER-2 YVMA • HER-2 elevation
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Tukysa (tucatinib) • ELVN-002
    almost2years
    ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1a/1b, N=178, Recruiting, Enliven Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • BRAF V600E • HER-2 amplification • BRAF V600 • ALK mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002
    almost2years
    ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1a/1b, N=178, Not yet recruiting, Enliven Therapeutics
    New P1 trial
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • BRAF V600E • HER-2 amplification • BRAF V600 • ALK mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • ELVN-002