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    DRUG:

    exlinkibart (LVGN6051)

    i
    Other names: LVGN6051, LVGN 6051, LVGN-6051
    Associations

    News

    Trials
    Company:
    Lyvgen
    Drug class:
    CD137 agonist
    Related drugs:
    Associations

    News

    Trials
    14d
    Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=352, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    CD40 (CD40 Molecule)
    |
    Avastin (bevacizumab) • albumin-bound paclitaxel • cyclophosphamide • dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    18d
    KEYNOTE-A31: Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=276, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    18d
    Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=126, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting | Phase classification: P1a/1b --> P1 | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2024 --> Dec 2025
    Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    5ms
    A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P2, N=64, Recruiting, Lyvgen Biopharma Holdings Limited | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • exlinkibart (LVGN6051)
    7ms
    A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, Lyvgen Biopharma Holdings Limited
    New P2 trial • Combination therapy • Metastases
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • exlinkibart (LVGN6051)
    7ms
    Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=18, Completed, Lyvgen Biopharma Holdings Limited | Terminated --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    8ms
    Study of LVGN6051 (CD137 Agonist Antibody) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=18, Terminated, Lyvgen Biopharma Holdings Limited | N=50 --> 18 | Trial completion date: Jul 2024 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Oct 2023; The study was terminated due to product development strategy adjustment,there were no safety concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    11ms
    Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (MK-3475-A31/KEYNOTE-A31) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
    P1, N=276, Recruiting, Lyvgen Biopharma Holdings Limited | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    1year
    Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=352, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jul 2023 --> Feb 2027 | Trial primary completion date: Jul 2023 --> Feb 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD40 (CD40 Molecule)
    |
    Avastin (bevacizumab) • albumin-bound paclitaxel • cyclophosphamide • dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    over1year
    First-in-human, phase 1a dose finding of LVGN6051 CD137/4-1BB agonistic antibody with or without pembrolizumab in patients with advanced solid tumors. (ASCO 2023)
    We established the RP2Ds of LVGN6051 alone and in combination with pembrolizumab in this FIH phase 1a study. These regimens were well tolerated. Preliminary efficacy data showed encouraging anti-tumor activity in heavily pretreated pts who had progressed on ICI.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
    over2years
    A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=65, Recruiting, Lyvgen Biopharma Holdings Limited | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Focus V (anlotinib) • exlinkibart (LVGN6051)
    over2years
    A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=65, Not yet recruiting, Lyvgen Biopharma Holdings Limited
    New P1/2 trial • IO biomarker
    |
    TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    Focus V (anlotinib) • exlinkibart (LVGN6051)
    almost3years
    Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=352, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Nov 2021
    Enrollment open • Trial initiation date • Combination therapy
    |
    CD40 (CD40 Molecule)
    |
    Avastin (bevacizumab) • albumin-bound paclitaxel • cyclophosphamide • dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    3years
    Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=352, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial • Combination therapy
    |
    CD40 (CD40 Molecule)
    |
    Avastin (bevacizumab) • albumin-bound paclitaxel • cyclophosphamide • dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
    over4years
    [VIRTUAL] Bifunctional agonist antibody LVGN6051 activates CD137/4-1BB selectively in tumor microenvironment for cancer immunotherapy (AACR-II 2020)
    In addition, LVGN6051 showed no noticeable activity in inducing cytokine release in tested bloods or PBMCs. These preclinical data demonstrated that LVGN6051 represents a well differentiated 2nd generation CD137 agonist antibody supporting the ongoing clinical study of LVGN6051 in advanced or metastatic malignancies (ClinicalTrials.gov Identifier: NCT04130542).
    CD8 (cluster of differentiation 8)
    |
    exlinkibart (LVGN6051)