^
    6d
    LBL-007-CN-004: A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors (clinicaltrials.gov)
    P1/2, N=490, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2025 --> Jul 2026 | Trial primary completion date: Oct 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • gemcitabine • docetaxel • Tevimbra (tislelizumab-jsgr) • alcestobart (LBL-007)
    17d
    BGB-A317-LBL-007-202: A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=118, Active, not recruiting, BeiGene | Trial primary completion date: Sep 2024 --> May 2025
    Trial primary completion date
    |
    cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • alcestobart (LBL-007)
    1m
    Novel anti-LAG-3 antibody LBL-007 with anti-PD-1 blockade enhances antitumor immunity by promoting T cell-induced apoptosis. (PubMed, Sci Rep)
    The combination of LBL-007 and anti-PD-1 antibodies delayed tumor growth and promoted tumor cell apoptosis compared with monotherapy in human LAG-3 transgenic mice subjected to transplantation with colorectal tumor cells. Taken together, the combination of LBL-007 and anti-PD-1 antibodies plays an enhanced antitumor role by improving T cell viability and activity as well as by promoting T cell-induced apoptosis, thereby suggesting this combination as a potential effective strategy for cancer immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
    |
    alcestobart (LBL-007)
    3ms
    A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma (clinicaltrials.gov)
    P1, N=79, Completed, Nanjing Leads Biolabs Co.,Ltd | Recruiting --> Completed
    Trial completion
    |
    Loqtorzi (toripalimab-tpzi) • Inlyta (axitinib) • alcestobart (LBL-007)
    3ms
    A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Loqtorzi (toripalimab-tpzi) • alcestobart (LBL-007)
    4ms
    A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=200, Not yet recruiting, Nanjing Leads Biolabs Co.,Ltd
    New P1/2 trial
    |
    Loqtorzi (toripalimab-tpzi) • alcestobart (LBL-007)
    5ms
    BGB-HNSCC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=160, Active, not recruiting, BeiGene | Trial completion date: Jan 2027 --> May 2026 | Trial primary completion date: Jan 2027 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tevimbra (tislelizumab-jsgr) • alcestobart (LBL-007) • surzebiclimab (BGB-A425)
    6ms
    A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=80, Completed, Nanjing Leads Biolabs Co.,Ltd | Recruiting --> Completed | N=200 --> 80
    Trial completion • Enrollment change
    |
    Loqtorzi (toripalimab-tpzi) • alcestobart (LBL-007)
    6ms
    A novel fully human LAG-3 monoclonal antibody LBL-007 combined with PD-1 antibody inhibits proliferation, migration and invasion of tumor cells via blocking NF-κB pathway (PubMed, Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi)
    Treatment with the NF-κB signaling pathway agonist TNF-α reversed the suppressive effects of LBL-007 and BE0188 on tumor cell proliferation, invasion, migration, and NF-κB signaling. Conclusion LBL-007 and anti-PD-1 antibody synergistically inhibit the invasion, migration, and proliferation of A549 and MGC803 tumor cells by blocking the NF-κB signaling pathway.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    LAG3 (Lymphocyte Activating 3) • TNFA (Tumor Necrosis Factor-Alpha) • MMP2 (Matrix metallopeptidase 2) • MMP9 (Matrix metallopeptidase 9) • NFKBIA (NFKB Inhibitor Alpha 2)
    |
    alcestobart (LBL-007)
    7ms
    BGB-A317-LBL-007-202: A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=118, Active, not recruiting, BeiGene | Trial completion date: Sep 2025 --> May 2026
    Trial completion date
    |
    cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • alcestobart (LBL-007)
    7ms
    Liberty-201: A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=113, Active, not recruiting, BeiGene | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Apr 2026 --> May 2025
    Trial completion date • Trial primary completion date • Mismatch repair • pMMR
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • Avzivi (bevacizumab-tnjn) • alcestobart (LBL-007)
    7ms
    BGB-LC-201: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=400, Active, not recruiting, BeiGene | Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jul 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • pemetrexed • BGB-15025 • BGB-A445 • alcestobart (LBL-007)