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    DRUG:

    acasunlimab (GEN1046)

    i
    Other names: GEN1046, BNT311, DuoBody-PD-L1x4-1BB, GEN1046-DS, BNT 311, BNT-311, GEN 1046, GEN-1046
    Associations

    News

    Trials
    Company:
    Genmab
    Drug class:
    PD-L1 inhibitor, CD137 agonist
    Related drugs:
    Associations

    News

    Trials
    1m
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    5ms
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Recruiting, Genmab | Not yet recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    7ms
    Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07) (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Genmab
    New P2 trial • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    8ms
    Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody, combined with PD-1 blockade potentiates antitumor immunity via complementary immune modulatory effects. (PubMed, J Immunother Cancer)
    These preclinical results demonstrate that conditional 4-1BB stimulation combined with complete PD-1 blockade enhances antitumor immunity through complementary mechanisms. The acasunlimab and pembrolizumab combination is being evaluated in Phase 2 (NCT05117242) and pivotal Phase 3 (NCT06635824) trials in patients with metastatic non-small cell lung cancer after checkpoint inhibitor therapy failure.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • PD-L2 (Programmed Cell Death 1 Ligand 2) • IL2 (Interleukin 2) • GZMB (Granzyme B)
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    8ms
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | Trial primary completion date: Feb 2026 --> Apr 2025
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    1year
    GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=18, Completed, Genmab | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024 | Trial primary completion date: Aug 2025 --> Oct 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    1year
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | Trial completion date: Oct 2025 --> Feb 2026 | Trial primary completion date: Jan 2025 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    1year
    Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) (clinicaltrials.gov)
    P3, N=702, Recruiting, Genmab
    New P3 trial
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)
    1year
    Acasunlimab in combination with pembrolizumab reinvigorates anti-tumor immunity in patients with previously treated metastatic non-small cell lung cancer (NSCLC) (SITC 2024)
    The study was conducted in accordance with the International Council for Harmonisation E6(R2) guidelines on good clinical practice and the principles of the Declaration of Helsinki. All patients provided written informed consent.
    Combination therapy • Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
    |
    CD8 expression • HAVCR2 expression
    |
    PD-L1 IHC 22C3 pharmDx • GuardantOMNI
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    over1year
    GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Genmab | Trial completion date: Nov 2024 --> Aug 2025 | Trial primary completion date: Nov 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    over1year
    Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer (clinicaltrials.gov)
    P2, N=125, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Checkpoint inhibition • Metastases
    |
    Keytruda (pembrolizumab) • acasunlimab (GEN1046)
    over1year
    GEN1046 Safety Trial in Patients With Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=429, Active, not recruiting, Genmab | Trial completion date: Dec 2024 --> Oct 2025 | Trial primary completion date: Jun 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • docetaxel • acasunlimab (GEN1046)