^
    11d
    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)
    14d
    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)
    4ms
    CD40 Agonist and PD-1 Inhibitor in HNSCC (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Pennsylvania | Not yet recruiting --> Recruiting
    Enrollment open
    |
    dalnicastobart (LVGN7409) • pradusinstobart (LVGN3616)
    7ms
    Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov)
    P1, N=33, Completed, Lyvgen Biopharma Holdings Limited | Terminated --> Completed
    Trial completion • Tumor mutational burden • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • CD40 (CD40 Molecule)
    |
    MSI-H/dMMR
    |
    dalnicastobart (LVGN7409)
    11ms
    Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov)
    P1, N=33, Terminated, Lyvgen Biopharma Holdings Limited | N=93 --> 33 | Trial completion date: Apr 2024 --> Dec 2023 | Recruiting --> Terminated; The study was terminated due to product development strategy adjustment,there were no safety concerns
    Enrollment change • Trial completion date • Trial termination • Tumor mutational burden • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • CD40 (CD40 Molecule)
    |
    MSI-H/dMMR
    |
    dalnicastobart (LVGN7409)
    11ms
    Harnessing the potential of CD40 agonism in cancer therapy. (PubMed, Cytokine Growth Factor Rev)
    In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.
    Review • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • CD40 (CD40 Molecule) • CD40LG (CD40 ligand)
    |
    CDX-1140 • cifurtilimab (SEA-CD40) • dalnicastobart (LVGN7409) • mitazalimab (ADC-1013) • selicrelumab (RG7876) • sotigalimab (PYX-107)
    11ms
    CD40 Agonist and PD-1 Inhibitor in HNSCC (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, University of Pennsylvania
    New P1 trial
    |
    dalnicastobart (LVGN7409) • pradusinstobart (LVGN3616)
    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)
    almost3years
    Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov)
    P1, N=93, Recruiting, Lyvgen Biopharma Holdings Limited
    Clinical • New P1 trial
    |
    CD4 (CD4 Molecule)
    |
    dalnicastobart (LVGN7409)
    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)