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    DRUG:

    Puyouheng (pucotenlimab)

    i
    Other names: HX008, HX 008, HX-008, LP001, AK103
    Company:
    HanX Biopharma, Lepu Med, Taizhou Hanzhong Biopharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    BLOOM-ON: Becotatug Vedotin Combined With Pucotenlimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=102, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    5d
    A Prospective, Single-arm, Phase II Clinical Trial of Becotatug Vedotin for Injection Combined With Pucotenlimab Injection as a First-line Treatment for Platinum-intolerant Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
    New P2 trial
    |
    IL2 (Interleukin 2)
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    6d
    PRAD2: Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=39, Not yet recruiting, Anhui Provincial Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    21d
    Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations (clinicaltrials.gov)
    P2/3, N=164, Not yet recruiting, Sir Run Run Shaw Hospital
    New P2/3 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    cisplatin • gemcitabine • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    26d
    GATEWAY: Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study (clinicaltrials.gov)
    P2, N=42, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    27d
    Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Lepu Biopharma Co., Ltd.
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    27d
    A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, Taizhou Hanzhong biomedical co. LTD | Recruiting --> Active, not recruiting
    Enrollment closed • Mismatch repair • MSI-H • dMMR
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • Puyouheng (pucotenlimab)
    1m
    Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid Tumors. (PubMed, Cancer Med)
    Network analysis recommended regimens: gemcitabine/cisplatin for TNBC (SUCRA = 95.7%), oxaliplatin/capecitabine for G/GEJ cancer (ORR = 60.0% vs. irinotecan 27.6%, HR = 0.45). The integrated model classified high-benefit (≥ 3 points; ORR 78.2%) and low-benefit (≤ 0 points; ORR 28.3%) groups, plus high-risk (≤ -2 points; grade ≥ 3 irAEs 41.2%) and low-risk (≥ 1 point; irAEs 3.5%) groups, validated by decision curve analysis. This defines precise application scenarios and provides an extensible analytical paradigm.
    Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • KMT2D (Lysine Methyltransferase 2D) • CCL11 (C-C Motif Chemokine Ligand 11)
    |
    MSI-H/dMMR
    |
    cisplatin • gemcitabine • capecitabine • oxaliplatin • irinotecan • Puyouheng (pucotenlimab)
    2ms
    A Randomized, Open-Label, Exploratory Phase II Clinical Study of MRG003 in Combination with Anti-EGFR Monoclonal Antibody and Pucotenlimab versus Investigator's Choice of Treatment in Patients with EGFR-Positive Esophageal Squamous Cell Carcinoma Who Failed First-Line Standard Therapy (ChiCTR2600121404)
    P=N/A, N=74, Zhejiang Provincial People's Hospital; Zhejiang Provincial People's Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    2ms
    The Efficacy and Safety of Becotatug Vedotin and Pucotenlimab as Neoadjuvant Therapy in Locally Advanced Laryngeal Cancer (IGNITE-Larynx) (ChiCTR2600120886)
    P2, N=55, Eye & ENT Hospital, Fudan University; Department of Otorhinolaryngology Head and Neck Surgery
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    2ms
    Neoadjuvant Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma (OSCC) (clinicaltrials.gov)
    P2, N=26, Not yet recruiting, Shanghai Zhongshan Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    PD-L1 expression • EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    2ms
    A single-center, double-cohort, open-label clinical trial evaluating the safety and efficacy of vebecotota monoclonal antibody for injection, either in combination or alone with putrilimab injection, in patients with recurrent or metastatic salivary gland cancer (ChiCTR2600118473)
    P2, N=90, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)