A Study of SGN-PDL1V in Advanced Solid Tumors

Last updated: April 15, 2025
Sponsor: Seagen Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Gastric Cancer

Head And Neck Cancer

Esophageal Disorders

Treatment

SGN-PDL1V

pembrolizumab

PF-08046054

Clinical Study ID

NCT05208762
SGNPDL1V-001
2021-003517-19
2023-506604-18-00
C5851001
  • Ages > 18
  • All Genders

Study Summary

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.

Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Parts A and B:

  • Participants must have one of the following histologically- orcytologically-confirmed metastatic or unresectable solid tumor types

  • Non-small cell lung cancer (NSCLC)

  • Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngealcancer)

  • Esophageal squamous cell carcinoma (SCC)

  • Triple negative breast cancer (TNBC)

  • Participants must have disease that is relapsed or refractory, that hasprogressed on approved therapies, be intolerant to or refused such therapies,or such and therapies are contraindicated and in the judgement of theinvestigator, should have no appropriate SoC therapeutic option

  • Participants must have PD-L1 expression based on historical testing

  • Part C:

  • Participants must have disease that is relapsed or refractory or be intolerantto SoC therapies and must have one of the following tumor types

  • HNSCC

  • Participants with HNSCC must have histologically orcytologically-confirmed HNSCC

  • NSCLC

  • Participants must have histologically or cytologically-confirmedNSCLC. Participants with SCC and non--SCC histology are eligible.Note: Participants with a neuroendocrine component or histology arenot eligible.

  • Esophageal SCC

  • Ovarian cancer

  • Melanoma

  • TNBC

  • Gastric cancer

  • Participants must have been previously tested for PD-L1 expression and shouldhave PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing

  • Part D and Part E:

  • Participants must have histologically or cytologically-confirmed disease of theHNSCC or NSCLC

  • Participants must have PD-L1 expression based on historical testing

  • Participants with NSCLC; PD-L1 expression ≥ 1% by TPS

  • Participants with HNSCC; PD--L1 expression ≥1 by CPS

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

  • Measurable disease per RECIST v1.1 at baseline

Exclusion

Exclusion Criteria:

  • History of another malignancy within 3 years of first dose of study treatment or anyevidence of residual disease from a previously diagnosed malignancy.

  • Known active central nervous system metastases. Participants with previously-treatedbrain metastases may participate provided they:

  • Are clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment

  • Have no new or enlarging brain metastases

  • And are off of corticosteroids prescribed for symptoms associate with brainmetastases for at least 7 days prior to first dose of study treatment

  • Lepto-meningeal disease

  • Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. Thisduration of time will vary according to the half-life of the specific agent.

  • Previous receipt of an monomethylauristatin E (MMAE)-containing agent.

  • Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI CTCAE) v5.0.

There are additional inclusion criteria. The study center will determine if criteria for participations are met.

Study Design

Total Participants: 315
Treatment Group(s): 3
Primary Treatment: SGN-PDL1V
Phase: 1
Study Start date:
October 25, 2022
Estimated Completion Date:
November 17, 2028

Connect with a study center

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • McGill University Department of Oncology / McGill University Health Centre

    Montreal, Quebec H3H 2R9
    Canada

    Active - Recruiting

  • McGill University Health Centre

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Institut Curie

    Paris cedex 05, Other 75005
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, Other 94805
    France

    Active - Recruiting

  • Clinique Ambroise Pare

    Neuilly sur seine, 92200
    France

    Active - Recruiting

  • lnstitut Curie Pharmacy

    Paris, 75005
    France

    Active - Recruiting

  • Institut Curie

    Paris Cedex 05, 75248
    France

    Active - Recruiting

  • Gustave Roussy Institute - Service pharmacie

    Villejuif, 94805
    France

    Active - Recruiting

  • Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin, 12200
    Germany

    Active - Recruiting

  • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

    Milano, Milan 20141
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano, Other 20141
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, Other 37136
    Italy

    Active - Recruiting

  • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi

    Verona, Other 37134
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi

    Verona, Veneto 37134
    Italy

    Active - Recruiting

  • Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, Other 1066CX
    Netherlands

    Active - Recruiting

  • The Netherlands Cancer Institute

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • CETIR Viladomat

    Barcelona, Other 08029
    Spain

    Active - Recruiting

  • Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)

    Barcelona, Other 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Other 08035
    Spain

    Active - Recruiting

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    Barcelona, Other 08908
    Spain

    Active - Recruiting

  • START Madrid-CIOCC_Hospital HM Sanchinarro

    Madrid, Other 28050
    Spain

    Active - Recruiting

  • Hospital Quiron Salud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Sarah Cannon Research Institute UK

    London, Other W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Harley Street Clinic (THSC)

    London, Other W1G 8BJ
    United Kingdom

    Active - Recruiting

  • The Royal Marsden Hospital

    Surrey, Other SM2 5PT
    United Kingdom

    Site Not Available

  • Diagnostic Centre

    London, Others WlG 7AF
    United Kingdom

    Active - Recruiting

  • Pharmacy: Royal Marsden Hospital

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • Radiology

    London, W1G 8PP
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • University of Alabama at Birmingham, IDS Pharmacy

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Chao Family Comprehensive Cancer Center University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • University of California Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Case Western Reserve University / University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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