A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
3 other identifiers
interventional
714
11 countries
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2022
Longer than P75 for phase_1
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 4, 2029
April 20, 2026
April 1, 2026
5.2 years
December 15, 2021
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of participants with adverse events (AEs)
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
Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Through the first cycle of study treatment; approximately 1 month
Secondary Outcomes (8)
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Up to approximately 3 years
Overall survival (OS)
Up to approximately 3 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Through 30-37 days after last study treatment; up to approximately 3 years
- +3 more secondary outcomes
Study Arms (2)
PF-08046054 Monotherapy
EXPERIMENTALPF-08046054 monotherapy
PF-08046054 Combination Therapy
EXPERIMENTALPF-08046054 + pembrolizumab
Interventions
200 mg once every 3 weeks given into the vein (IV; intravenously)
Given into the vein (IV; intravenously)
Eligibility Criteria
You may qualify if:
- 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
- +13 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute
Farmington Hills, Michigan, 48334, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75235, United States
UT Southwestern Medical Center - Redbird
Dallas, Texas, 75237, United States
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas, 75390, United States
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Southwestern - Simmons Cancer Center - Fort Worth
Fort Worth, Texas, 76104, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
UT Southwestern - Simmons Cancer Center - Richardson/Plano
Richardson, Texas, 75080, United States
NEXT Virginia, LLC
San Antonio, Texas, 78229, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Institut Jules Bordet
Anderlecht, 1070, Belgium
University Health Network
Toronto, Ontario, M5G 2C4, Canada
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 101100, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Hôpital Saint André - CHU Bordeaux
Bordeaux, 33075, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
lnstitut Curie Pharmacy
Paris, 75005, France
Institut Curie
Paris, 75248, France
Gustave Roussy Institute - Service pharmacie
Villejuif, 94805, France
Charite Comprehensive Cancer Center
Berlin, 10117, Germany
Charite Universitatsmedizin Berlin
Berlin, 12200, Germany
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
Berlin, 13353, Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan, Milan, 20141, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
Verona, Other, 37134, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
Verona, Veneto, 37134, Italy
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
Bologna, 40138, Italy
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
The Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
CETIR Viladomat
Barcelona, Other, 08029, Spain
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
Barcelona, Other, 08908, Spain
Hospital Quiron Salud Barcelona
Barcelona, 08023, Spain
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Diagnostic Centre
London, Others, W1G 7AF, United Kingdom
The Harley Street Clinic (THSC)
London, Other, W1G 8BJ, United Kingdom
Pharmacy: Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
Radiology
London, W1G 8PP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2021
First Posted
January 26, 2022
Study Start
October 25, 2022
Primary Completion (Estimated)
January 5, 2028
Study Completion (Estimated)
January 4, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.