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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:
    13d
    KN046-209: Study of KN046 in Subjects With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=95, Completed, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting --> Completed | N=54 --> 95 | Trial completion date: Dec 2027 --> Dec 2025
    Trial completion • Enrollment change • Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    ALK translocation • EGFR negative
    |
    axitinib • erfonrilimab (KN046)
    1m
    A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=15, Terminated, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | N=42 --> 15 | Recruiting --> Terminated; Due to R&D strategy adjustments; no safety issues involved.
    Enrollment change • Trial termination
    |
    erfonrilimab (KN046) • Zepsun (donafenib)
    7ms
    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)
    1year
    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) • Ennituo (anbenitamab)
    1year
    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) • Ennituo (anbenitamab)
    over1year
    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)
    almost2years
    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)
    2years
    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) • Ennituo (anbenitamab)
    2years
    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
    |
    axitinib • erfonrilimab (KN046)
    2years
    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) • Ennituo (anbenitamab)
    2years
    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)
    2years
    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)