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    DRUG:

    sigvotatug vedotin (PF-08046047)

    i
    Other names: PF-08046047, SGN-B6A, SGNB6A, SGN B6A, PF08046047, PF 08046047
    Company:
    Pfizer
    Drug class:
    Microtubule inhibitor, Integrin beta-6 -targeted antibody-drug conjugate
    Related drugs:
    2ms
    A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=12, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    sigvotatug vedotin (PF-08046047)
    3ms
    A Study of SGN-B6A in Chinese Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Seagen Inc.
    New P1 trial • Metastases
    |
    sigvotatug vedotin (PF-08046047)
    4ms
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=824, Recruiting, Seagen Inc. | Trial completion date: Oct 2028 --> Feb 2028
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • sigvotatug vedotin (PF-08046047)
    8ms
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=824, Recruiting, Seagen Inc. | Trial completion date: Oct 2024 --> Oct 2028 | Trial primary completion date: Jul 2024 --> Nov 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • sigvotatug vedotin (PF-08046047)
    9ms
    Be6A Lung-01: A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=600, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting | Trial completion date: Jan 2029 --> Jul 2028 | Initiation date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2026 --> Jul 2026
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    docetaxel • sigvotatug vedotin (PF-08046047)
    1year
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=1006, Recruiting, Seagen Inc. | N=572 --> 1006
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • sigvotatug vedotin (PF-08046047)
    1year
    A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=560, Not yet recruiting, Seagen Inc.
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    docetaxel • sigvotatug vedotin (PF-08046047)
    1year
    SGN-B6A: A New Vedotin Antibody-Drug Conjugate Directed to Integrin Beta-6 for Multiple Carcinoma Indications. (PubMed, Mol Cancer Ther)
    Hematologic toxicities typical of MMAE ADCs were dose limiting, and no significant target-mediated toxicity was observed. A phase 1 first-in-human study is in progress to evaluate the safety and antitumor activity of SGN-B6A in a variety of solid tumors known to express integrin beta-6 (NCT04389632).
    Journal
    |
    sigvotatug vedotin (PF-08046047)
    over1year
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=572, Recruiting, Seagen Inc. | N=355 --> 572
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • sigvotatug vedotin (PF-08046047)
    over1year
    SGN-B6A induces immunogenic cell death as an additional mechanism of action (AACR 2023)
    The combination of SGN-B6A with immunotherapy may be utilized as a potential treatment for integrin-beta-6-expressing tumors including NSCLC, head and neck squamous cell carcinoma, and esophageal carcinoma. Altogether, our preclinical and initial clinical results support the ongoing evaluation of SGN-B6A as a single agent and in combination with immune checkpoint inhibitors.
    IO biomarker
    |
    HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    sigvotatug vedotin (PF-08046047)
    over2years
    SGNB6A-001: A Study of SGN-B6A in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=355, Recruiting, Seagen Inc. | Trial completion date: Nov 2023 --> Oct 2024 | Trial primary completion date: Nov 2023 --> Jul 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    sigvotatug vedotin (PF-08046047)