A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
NCT ID: NCT05208762
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
315 participants
INTERVENTIONAL
2022-10-25
2028-04-08
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-08046054 Monotherapy
PF-08046054 monotherapy
PF-08046054
Given into the vein (IV; intravenously)
PF-08046054 Combination Therapy
PF-08046054 + pembrolizumab
PF-08046054
Given into the vein (IV; intravenously)
pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Interventions
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PF-08046054
Given into the vein (IV; intravenously)
pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Ovarian cancer
* Melanoma
* TNBC
* Gastric 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
* 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.
18 Years
ALL
No
Sponsors
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Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
The University of Iowa
Iowa City, Iowa, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center - Redbird
Dallas, Texas, United States
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas, United States
University Of Texas Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern - Simmons Cancer Center - Fort Worth
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
UT Southwestern - Simmons Cancer Center - Richardson/Plano
Richardson, Texas, United States
NEXT Virginia, LLC
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Institut Jules Bordet
Anderlecht, , Belgium
University Health Network
Toronto, Ontario, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Hôpital Saint André - CHU Bordeaux
Bordeaux, , France
Clinique Ambroise Pare
Neuilly-sur-Seine, , France
lnstitut Curie Pharmacy
Paris, , France
Institut Curie
Paris, , France
Gustave Roussy Institute - Service pharmacie
Villejuif, , France
Charite Comprehensive Cancer Center
Berlin, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
Berlin, , Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan, Milan, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
Verona, Other, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
Verona, Veneto, Italy
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
Bologna, , Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
The Netherlands Cancer Institute
Amsterdam, , Netherlands
CETIR Viladomat
Barcelona, Other, Spain
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
Barcelona, Other, Spain
Hospital Quiron Salud Barcelona
Barcelona, , Spain
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, , Spain
Diagnostic Centre
London, Others, United Kingdom
The Harley Street Clinic (THSC)
London, Other, United Kingdom
Pharmacy: Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Radiology
London, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5851001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506604-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
SGNPDL1V-001
Identifier Type: -
Identifier Source: org_study_id