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    DRUG:

    fetrastobart vedotin (PF-08046054)

    i
    Other names: Fetra-V, PF-08046054, SGN-PDL1V, PF08046054, SGNPDL1V, PF 08046054, SGN PDL1V
    Company:
    Pfizer
    Drug class:
    Microtubule inhibitor, PD-L1-targeted antibody-drug conjugate
    Related drugs:
    4ms
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=714, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | N=315 --> 714 | Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Apr 2027 --> Jan 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    4ms
    C5851005: A Study to Learn About the Study Medicine Called PF-08046054/SGNPDL1V Versus Docetaxel in Adult Participants with Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-small-cell Lung Cancer (NSCLC) (2025-521281-97-00)
    P2/3, N=246, Recruiting, Pfizer Inc.
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR mutation • ALK translocation
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    docetaxel • fetrastobart vedotin (PF-08046054)
    8ms
    A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=680, Recruiting, Pfizer | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    docetaxel • fetrastobart vedotin (PF-08046054)
    10ms
    A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=680, Not yet recruiting, Pfizer
    New P3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    docetaxel • fetrastobart vedotin (PF-08046054)
    1year
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=315, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Sep 2027 --> Apr 2028 | Trial primary completion date: Sep 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    1year
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=315, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Nov 2028 --> Sep 2027 | Trial primary completion date: Nov 2027 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    over1year
    SGNPDL1V-001: A Study of SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=315, Recruiting, Seagen Inc. | Trial completion date: Dec 2027 --> Nov 2028 | Trial primary completion date: Jul 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    almost2years
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=438, Recruiting, Seagen Inc. | Trial completion date: Dec 2026 --> Dec 2027
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    almost2years
    SGNPDL1V-001: A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=438, Recruiting, Seagen Inc. | N=322 --> 438
    Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • fetrastobart vedotin (PF-08046054)
    4years
    Phase 1 study of SGN-PDL1V, a novel, investigational vedotin antibody–drug conjugate directed to PD-L1, in patients with advanced solid tumors (SGNPDL1V-001, trial in progress). (ASCO 2022)
    Objective response rate will be analyzed by tumor type, dose levels, and schedules. Enrollment for Part A is ongoing at sites in North America and is planned in Europe.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    fetrastobart vedotin (PF-08046054)