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    DRUG:

    felmetatug vedotin (PF-08046048)

    i
    Other names: PF-08046048, SGN-B7H4V, PF08046048, SGNB7H4V, PF 08046048, SGN B7H4V
    Company:
    Pfizer
    Drug class:
    Microtubule inhibitor, B7-H4-targeted antibody-drug conjugate
    Related drugs:
    9d
    SGNB7H4V-001: A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=572, Recruiting, Seagen Inc. | N=430 --> 572 | Trial completion date: Jan 2027 --> Nov 2027 | Trial primary completion date: Jun 2025 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    Keytruda (pembrolizumab) • felmetatug vedotin (PF-08046048)
    1year
    SGNB7H4V-001: A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=400, Recruiting, Seagen Inc. | Active, not recruiting --> Recruiting | N=164 --> 400
    Enrollment open • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    felmetatug vedotin (PF-08046048)
    1year
    SGN-B7H4V, an investigational vedotin ADC directed to the immune checkpoint ligand B7-H4, shows promising activity in preclinical models. (PubMed, J Immunother Cancer)
    The immune checkpoint ligand B7-H4 is a promising molecular target expressed by multiple solid tumors. SGN-B7H4V demonstrates robust antitumor activity in preclinical models through multiple potential mechanisms. Altogether, these preclinical data support the evaluation of SGN-B7H4V as a monotherapy in the ongoing phase 1 study of SGN-B7H4V in advanced solid tumors (NCT05194072) and potential future clinical combinations with immunotherapies.
    Preclinical • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    Adcetris (brentuximab vedotin) • Padcev (enfortumab vedotin-ejfv) • felmetatug vedotin (PF-08046048) • Tivdak (tisotumab vedotin-tftv)
    1year
    SGNB7H4V-001: A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=164, Active, not recruiting, Seagen Inc. | Recruiting --> Active, not recruiting | N=400 --> 164
    Enrollment closed • Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    felmetatug vedotin (PF-08046048)
    over1year
    First-in-human study of SGN-B7H4V, a B7-H4-directed vedotin ADC, in patients with advanced solid tumors: Preliminary results of a phase I study (SGNB7H4V-001) (ESMO 2023)
    Responses were observed at all tested dose levels and across various tumor types. Dose expansion in select tumor types is planned.
    Clinical • P1 data • Metastases
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    felmetatug vedotin (PF-08046048)
    2years
    SGN-B7H4V induces immunomodulatory changes to the tumor microenvironment and pairs well with an anti-PD1 agent in a preclinical model (SITC 2022)
    This vedotin drug linker system has been clinically validated in multiple ADC programs, including brentuximab vedotin, enfortumab vedotin, and tisotumab vedotin. Moreover, SGN-B7H4V in combination with an anti-PD1 agent led to improved antitumor activity and elicited durable immune memory. Altogether, these nonclinical data further support the evaluation of SGN-B7H4V as a monotherapy in the ongoing Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors ( NCT05194072 ) and potential future clinical combinations with immunotherapies.
    Preclinical • PD(L)-1 Biomarker • IO biomarker
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    VTCN1 underexpression
    |
    Adcetris (brentuximab vedotin) • Padcev (enfortumab vedotin-ejfv) • felmetatug vedotin (PF-08046048) • Tivdak (tisotumab vedotin-tftv)
    over2years
    Phase 1 study of SGN-B7H4V, a novel, investigational vedotin antibody–drug conjugate directed to B7-H4, in patients with advanced solid tumors (SGNB7H4V-001, trial in progress). (ASCO 2022)
    DOR, PFS, and OS will be estimated using the Kaplan–Meier method. Enrollment for Part A is ongoing in North America and is planned in Europe.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1)
    |
    HR positive • HER-2 negative • VTCN1 underexpression
    |
    felmetatug vedotin (PF-08046048)
    over2years
    SGN-B7H4V shows immunomodulatory activity through induction of immunogenic cell death (AACR 2022)
    This vedotin drug linker system has been clinically validated by multiple ADC programs, including brentuximab vedotin, enfortumab vedotin, tisotumab vedotin, and polatuzumab vedotin. Finally, SGN-B7H4V drove robust, curative activity in an immunocompetent tumor model as a monotherapy and paired well with an anti-PD1 agent. Altogether, these data support the evaluation of SGN-B7H4V as a monotherapy in a first-in-human phase 1 clinical study and potential future clinical combinations with immunotherapies.
    PD(L)-1 Biomarker • IO biomarker
    |
    VTCN1 (V-Set Domain Containing T Cell Activation Inhibitor 1) • CALR (Calreticulin)
    |
    VTCN1 underexpression
    |
    Adcetris (brentuximab vedotin) • Padcev (enfortumab vedotin-ejfv) • felmetatug vedotin (PF-08046048) • Polivy (polatuzumab vedotin-piiq) • Tivdak (tisotumab vedotin-tftv)
    almost3years
    A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=355, Recruiting, Seagen Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    felmetatug vedotin (PF-08046048)
    almost3years
    A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=355, Not yet recruiting, Seagen Inc.
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    felmetatug vedotin (PF-08046048)