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    DRUG:

    erfonrilimab (KN046)

    i
    Other names: KN046, KN-046, KN 046
    Company:
    Alphamab
    Drug class:
    PD-L1 inhibitor, CTLA4 inhibitor
    Related drugs:
    1m
    Clinical Study on Pathological Remission and Safety of JSKN003 Combined with KN046 New Adjuvant Therapy for muscle-invasive bladder cancer (ChiCTR2500109757)
    P=N/A, N=20, Recruiting, harbin medical university cancer hospital; harbin medical university cancer hospital
    New trial
    |
    erfonrilimab (KN046) • anbenitamab repodatecan (JSKN003)
    8ms
    Safety and Efficacy of KN046 in combination with KN026 in Patients with advanced HER2-positive Breast Cancer: a Phase II Trial. (PubMed, Clin Cancer Res)
    The combination of KN046 and KN026, as a chemo free regimen, demonstrated favorable clinical efficacy with comparative toxicities in pre-treated patients with advanced HER2-positive breast cancer.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    9ms
    Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. (PubMed, Signal Transduct Target Ther)
    In the other HER2-positive solid tumor subgroup (n = 34), the ORR was 52.9% (95%CI 35.1%,70.2%). Thus, KN026 plus KN04 exhibits promising efficacy and acceptable safety profiles in HER2-positive nonbreast cancer, as does the 1st-line treatment for GC.
    P1 data • P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD4 (CD4 Molecule)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    10ms
    The anti-PD-L1/CTLA-4 bispecific antibody KN046 plus lenvatinib in advanced unresectable or metastatic hepatocellular carcinoma: a phase II trial. (PubMed, Nat Commun)
    Circulating tumor DNA status before the third cycle of treatment was associated with prognosis. In conclusion, First-line KN046 plus lenvatinib shows promising efficacy for advanced unresectable or metastatic HCC.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Lenvima (lenvatinib) • erfonrilimab (KN046)
    over1year
    Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=41, Recruiting, Shanghai Zhongshan Hospital | Trial primary completion date: Jun 2024 --> Nov 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046) • Sulanda (surufatinib)
    over1year
    Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC (clinicaltrials.gov)
    P2, N=18, Recruiting, Peking University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    capecitabine • oxaliplatin • erfonrilimab (KN046) • anbenitamab (KN026)
    over1year
    Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=54, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Enrolling by invitation --> Recruiting | Trial completion date: Mar 2024 --> Dec 2027 | Trial primary completion date: Mar 2023 --> May 2027
    Enrollment status • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    ALK translocation • EGFR negative
    |
    Inlyta (axitinib) • erfonrilimab (KN046)
    over1year
    KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor (clinicaltrials.gov)
    P1, N=48, Completed, Peking University | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    erfonrilimab (KN046) • anbenitamab (KN026)
    over1year
    KN046, a bispecific antibody against PD-L1 and CTLA-4, plus chemotherapy as first-line treatment for metastatic NSCLC: A multicenter phase 2 trial. (PubMed, Cell Rep Med)
    In this multicenter phase 2 trial, patients with nonsquamous (non-sq) NSCLC receive pemetrexed, whereas those with sq-NSCLC receive paclitaxel, plus KN046 and carboplatin. These findings indicate that first-line treatment with KN046 and chemotherapy is effective and tolerable in metastatic NSCLC patients, warranting further investigation in a larger phase 3 trial. The trial is registered at ClinicalTrials.gov (NCT04054531).
    P2 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • paclitaxel • pemetrexed • erfonrilimab (KN046)
    over1year
    The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=55, Completed, Peking University Cancer Hospital & Institute | Recruiting --> Completed | Trial completion date: May 2023 --> Mar 2024
    Trial completion • Trial completion date • Combination therapy • Metastases
    |
    Lenvima (lenvatinib) • erfonrilimab (KN046)
    over1year
    ENREACH-Thymic: KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma (clinicaltrials.gov)
    P2, N=95, Terminated, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | The overall safety of KN046 is good, and no new safety signals have been found. The decision to terminate this study was made due to the adjustment of the sponsor's development strategy.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    erfonrilimab (KN046)
    over1year
    ENREACH-PDAC-01: KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma. (clinicaltrials.gov)
    P3, N=408, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • erfonrilimab (KN046)