A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Last updated: December 5, 2025
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Squamous Cell Carcinoma

Lung Cancer

Treatment

PF-08046054

SGN-PDL1V

pembrolizumab

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: PF-08046054
Phase: 1
Study Start date:
October 25, 2022
Estimated Completion Date:
April 08, 2028

Connect with a study center

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Anderlecht 2803201, 1070
    Belgium

    Active - Recruiting

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • University Health Network

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Active - Recruiting

  • University Health Network, Princess Margaret Hospital

    Toronto 6167865, Ontario 6093943 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

    Site Not Available

  • McGill University Health Centre

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing 1816670, Beijing Municipality 2038349 101100
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100050
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430000
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, Shanghai 200123
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200123
    China

    Active - Recruiting

  • Institut Curie

    Paris cedex 05, Other 75005
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, Other 94805
    France

    Active - Recruiting

  • Hôpital Saint André - CHU Bordeaux

    BORDEAUX Cedex, 33075
    France

    Site Not Available

  • Hôpital Saint André - CHU Bordeaux

    Bordeaux 3031582, 33075
    France

    Active - Recruiting

  • Clinique Ambroise Pare

    Neuilly sur seine, 92200
    France

    Site Not Available

  • Clinique Ambroise Pare

    Neuilly-sur-Seine 2990611, 92200
    France

    Active - Recruiting

  • lnstitut Curie Pharmacy

    Paris, 75005
    France

    Site Not Available

  • Institut Curie

    Paris 2988507, 75248
    France

    Active - Recruiting

  • lnstitut Curie Pharmacy

    Paris 2988507, 75005
    France

    Active - Recruiting

  • Institut Curie

    Paris Cedex 05, 75248
    France

    Site Not Available

  • Gustave Roussy Institute - Service pharmacie

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy Institute - Service pharmacie

    Villejuif 2968705, 94805
    France

    Active - Recruiting

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

    Berlin, 13353
    Germany

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin, 12200
    Germany

    Site Not Available

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

    Berlin 2950159, 13353
    Germany

    Active - Recruiting

  • Charite Comprehensive Cancer Center

    Berlin 2950159, 10117
    Germany

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin 2950159, 12200
    Germany

    Active - Recruiting

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

    Milan 6951411, Milan 20141
    Italy

    Active - Recruiting

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

    Milano, Milan 20141
    Italy

    Site Not Available

  • 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

    Site Not Available

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

    Verona 3164527, Other 37134
    Italy

    Active - Recruiting

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

    Verona, Veneto 37134
    Italy

    Active - Recruiting

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

    Verona 3164527, Veneto 3164604 37134
    Italy

    Active - Recruiting

  • UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa 1859924, Chiba 2113014 277-8577
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka 1851715 411-8777
    Japan

    Active - Recruiting

  • Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, Other 1066CX
    Netherlands

    Active - Recruiting

  • The Netherlands Cancer Institute

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • The Netherlands Cancer Institute

    Amsterdam 2759794, 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

  • CETIR Viladomat

    Barcelona 3128760, Other 08029
    Spain

    Active - Recruiting

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

    Barcelona 3128760, 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

    Site Not Available

  • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Quiron Salud Barcelona

    Barcelona 3128760, 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

    Barcelona 3128760, 08023
    Spain

    Active - Recruiting

  • START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

    Madrid 3117735, 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 Harley Street Clinic (THSC)

    London 2643743, 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

    Site Not Available

  • Diagnostic Centre

    London 2643743, Others W1G 7AF
    United Kingdom

    Active - Recruiting

  • Pharmacy: Royal Marsden Hospital

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • Pharmacy: Royal Marsden Hospital

    Sutton 2636503, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    Sutton 2636503, 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

  • Radiology

    London 2643743, W1G 8PP
    United Kingdom

    Active - Recruiting

  • Sarah Cannon Research Institute

    London 2643743, W1G 6AD
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust

    London 2643743, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama at Birmingham, IDS Pharmacy

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35249
    United States

    Active - Recruiting

  • University of Alabama at Birmingham, IDS Pharmacy

    Birmingham 4049979, Alabama 4829764 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

    Site Not Available

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine 5359777, California 5332921 92612
    United States

    Site Not Available

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • University of California Davis Comprehensive Cancer Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • University of California, Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • The University of Iowa

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Farmington Hills 4992523, Michigan 5001836 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

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 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

    Site Not Available

  • 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

    Site Not Available

  • UT Southwestern Medical Center - Redbird

    Dallas 4684888, Texas 4736286 75237
    United States

    Active - Recruiting

  • Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • University Of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • UT Southwestern - Simmons Cancer Center - Fort Worth

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • UT Southwestern - Simmons Cancer Center - Richardson/Plano

    Richardson 4722625, Texas 4736286 75080
    United States

    Active - Recruiting

  • NEXT Virginia, LLC

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio 4726206, Texas 4736286 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

    Site Not Available

  • START Mountain Region

    West Valley City 5784607, Utah 5549030 84119
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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