Actively Recruiting
A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-04-20
714
Participants Needed
61
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of a drug called PF-08046054/SGN-PDL1V alone and in combination with pembrolizumab in participants with solid tumors. The study focuses on people with metastatic or unresectable solid tumor cancers, including several types such as non-small cell lung cancer, head and neck squamous cell carcinoma, and triple negative breast cancer. This is a Phase 1 trial aiming to find appropriate dosing and assess safety and possible effects of these treatments. The study has five parts. Parts A and B will determine the correct dose of PF-08046054/SGN-PDL1V. Part C will test the safety and effectiveness of PF-08046054/SGN-PDL1V alone using the dose found earlier. Parts D and E will explore the safety and effects of combining PF-08046054/SGN-PDL1V with pembrolizumab. PF-08046054 is given intravenously, and pembrolizumab is given at 200 mg every 3 weeks also intravenously. Participants receive treatment based on the part they are assigned to. Participants will be monitored through various assessments including tracking adverse events, laboratory tests, and dose-limiting toxicities during the treatment and for up to three years after. Researchers will also measure tumor response, progression-free survival, overall survival, and drug levels in the body. The study includes regular checkups to evaluate safety and treatment impact. Participation duration and monitoring may last up to several years depending on treatment and follow-up progress.
CONDITIONS
Brief Title
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Participants must have metastatic or unresectable solid tumors confirmed by biopsy
- Specific tumor types include non-small cell lung cancer, head and neck squamous cell carcinoma (excluding nasopharyngeal cancer), esophageal squamous cell carcinoma, and triple negative breast cancer (Parts A and B)
- Disease must be relapsed, refractory, progressed on approved therapies, intolerant to or refused such therapies, or no appropriate standard treatment available
- Participants must have PD-L1 expression based on historical testing
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
- Additional tumor types and PD-L1 expression criteria apply for Parts C, D, and E as specified in the protocol
You will not qualify if you...
- History of another malignancy within 3 years before study treatment or evidence of residual disease from past malignancy
- Active central nervous system metastases unless clinically stable for at least 4 weeks after treatment and off corticosteroids for at least 7 days
- Leptomeningeal disease
- Prior anti-PD-L1 treatment within less than five half-lives of the agent
- Previous treatment with monomethylauristatin E (MMAE)-containing agents
- Pre-existing neuropathy Grade 2 or higher per NCI CTCAE v5.0
- Additional criteria as determined by the study center for participation eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive PF-08046054 alone or in combination with pembrolizumab through intravenous infusions as part of the study treatment.
Infusions every 3 weeks; visit frequency varies with treatment cycles
Duration - Up to 3 years after last study treatment
Participants are monitored for safety and long-term outcomes after completing the treatment phase.
Approximately 6 to 12 visits over 3 years
Trial Site Locations
Total: 61 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States, 35249
Actively Recruiting
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
4
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
5
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
6
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
8
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
9
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
10
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Karmanos Cancer Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
12
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
13
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, United States, 75235
Actively Recruiting
14
UT Southwestern Medical Center - Redbird
Dallas, Texas, United States, 75237
Actively Recruiting
15
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
16
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
17
University Of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
18
UT Southwestern - Simmons Cancer Center - Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
19
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, United States, 77030
Actively Recruiting
20
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
UT Southwestern - Simmons Cancer Center - Richardson/Plano
Richardson, Texas, United States, 75080
Actively Recruiting
22
NEXT Virginia, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
23
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
24
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
25
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
26
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
27
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
28
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
29
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
30
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
31
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
32
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China, 101100
Actively Recruiting
33
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
34
Hôpital Saint André - CHU Bordeaux
Bordeaux, France, 33075
Actively Recruiting
35
Clinique Ambroise Pare
Neuilly-sur-Seine, France, 92200
Actively Recruiting
36
lnstitut Curie Pharmacy
Paris, France, 75005
Actively Recruiting
37
Institut Curie
Paris, France, 75248
Actively Recruiting
38
Gustave Roussy Institute - Service pharmacie
Villejuif, France, 94805
Actively Recruiting
39
Charite Comprehensive Cancer Center
Berlin, Germany, 10117
Actively Recruiting
40
Charite Universitatsmedizin Berlin
Berlin, Germany, 12200
Actively Recruiting
41
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
Berlin, Germany, 13353
Actively Recruiting
42
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan, Milan, Italy, 20141
Actively Recruiting
43
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
Verona, Other, Italy, 37134
Actively Recruiting
44
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
Verona, Veneto, Italy, 37134
Actively Recruiting
45
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
Bologna, Italy, 40138
Actively Recruiting
46
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
47
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan, 411-8777
Actively Recruiting
48
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
49
CETIR Viladomat
Barcelona, Other, Spain, 08029
Actively Recruiting
50
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
Barcelona, Other, Spain, 08908
Actively Recruiting
51
Hospital Quiron Salud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
52
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
53
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
54
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
55
Diagnostic Centre
London, Others, United Kingdom, W1G 7AF
Actively Recruiting
56
The Harley Street Clinic (THSC)
London, Other, United Kingdom, W1G 8BJ
Actively Recruiting
57
Pharmacy: Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
58
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
59
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
60
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
61
Radiology
London, United Kingdom, W1G 8PP
Actively Recruiting
Research Team
S
Seagen Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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