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

April 17, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

714

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Anderlecht, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 101100
        • Recruiting
        • Beijing Friendship Hospital Affiliate of Capital University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200123
        • Recruiting
        • Shanghai East Hospital
  • France
      • Bordeaux, France, 33075
        • Recruiting
        • Hôpital Saint André - CHU Bordeaux
      • Neuilly-sur-Seine, France, 92200
        • Recruiting
        • Clinique Ambroise Pare
      • Paris, France, 75248
        • Recruiting
        • Institut Curie
      • Paris, France, 75005
        • Recruiting
        • lnstitut Curie Pharmacy
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy Institute - Service pharmacie
  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Charité Universitätsmedizin Berlin
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Comprehensive Cancer Center
      • Berlin, Germany, 13353
        • Recruiting
        • Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
    • Milan
      • Milan, Milan, Italy, 20141
        • Recruiting
        • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
    • Other
      • Verona, Other, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Shizuoka
      • Nagaizumi-cho, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • The Netherlands Cancer Institute
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08023
        • Recruiting
        • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital Quiron Salud Barcelona
      • Madrid, Spain, 28050
        • Recruiting
        • START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
    • Other
      • Barcelona, Other, Spain, 08029
        • Recruiting
        • CETIR Viladomat
      • Barcelona, Other, Spain, 08908
        • Recruiting
        • Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, W1G 8PP
        • Recruiting
        • Radiology
    • Other
      • London, Other, United Kingdom, W1G 8BJ
        • Recruiting
        • The Harley Street Clinic (THSC)
    • Others
      • London, Others, United Kingdom, W1G 7AF
        • Recruiting
        • Diagnostic Centre
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Pharmacy: Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham, IDS Pharmacy
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health - Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Karmanos Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Afshin Dowlati
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Medical Center - Redbird
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern Medical Center - Simmons Cancer Center
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern - Simmons Cancer Center - Fort Worth
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Maura Gillison
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern - Simmons Cancer Center - Richardson/Plano
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics, LLC
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Virginia, LLC
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parts A and B:

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

      • Non-small cell lung cancer (NSCLC)
      • Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
      • Esophageal squamous cell carcinoma (SCC)
      • Triple negative breast cancer (TNBC)
    • Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, 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 intolerant to SoC therapies and must have one of the following tumor types

      • HNSCC

        • Participants with HNSCC must have histologically or cytologically-confirmed HNSCC

      • NSCLC

        • Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
      • Esophageal SCC
      • Pancreatic cancer
      • Hepatocellular carcinoma
      • TNBC
      • Gastric cancer
      • Endometrial cancer
    • Participants must have been previously tested for PD-L1 expression and should have 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 the HNSCC 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 Criteria:

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

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

    • Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
    • Have no new or enlarging brain metastases
    • And are off of corticosteroids prescribed for symptoms associate with brain metastases 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. This duration 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 Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-08046054 Monotherapy
PF-08046054 monotherapy
Drug: PF-08046054
Given into the vein (IV; intravenously)
Other Names:
  • SGN-PDL1V
Experimental: PF-08046054 Combination Therapy
PF-08046054 + pembrolizumab
Drug: pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Other Names:
  • Keytruda
Drug: PF-08046054
Given into the vein (IV; intravenously)
Other Names:
  • SGN-PDL1V

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Through approximately 90 days after last study treatment; up to 3 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with laboratory abnormalities
Time Frame: Through approximately 90 days after last study treatment; up to 3 years
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: Through the first cycle of study treatment; approximately 1 month
Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Time Frame: Through the first cycle of study treatment; approximately 1 month
Through the first cycle of study treatment; approximately 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause.
Up to approximately 3 years
Overall survival (OS)
Time Frame: Up to approximately 3 years
The time from the start of study treatment to death due to any cause.
Up to approximately 3 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
Incidence of anti-drug antibodies (ADAs)
Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years
To be summarized using descriptive statistics
Through 30-37 days after last study treatment; up to approximately 3 years
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
Time Frame: Up to approximately 3 years
The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: Up to approximately 3 years
The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Estimated)

January 5, 2028

Study Completion (Estimated)

January 4, 2029

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNPDL1V-001
  • C5851001 (Other Identifier: Alias Study Number)
  • 2023-506604-18-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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