Carcinoma, Non-Small-Cell LungPhase 1NCT05208762
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
A Phase 1 study testing PF-08046054 and pembrolizumab in people with Carcinoma, Non-Small-Cell Lung and Squamous Cell Carcinoma of the Head and Neck, run by Seagen, a wholly owned subsidiary of Pfizer at 62 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma
- What is being tested?
- PF-08046054 and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 714 participants
- Where
- 62 sitesin 11 countries
- Study dates
- 25 Oct 2022to 4 Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
62 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 11 countries
United States25 sites, 25 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75235
- Recruiting
UT Southwestern Medical Center - Redbird
Dallas, Texas, 75237
- Recruiting
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
Dallas, Texas, 75390
- Recruiting
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas, 75390
- Recruiting
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
Karmanos Cancer Institute
Farmington Hills, Michigan, 48334
- Recruiting
UT Southwestern - Simmons Cancer Center - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
- Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868
- Recruiting
UT Southwestern - Simmons Cancer Center - Richardson/Plano
Richardson, Texas, 75080
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
- Recruiting
NEXT Virginia, LLC
San Antonio, Texas, 78229
- Recruiting
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
United Kingdom7 sites, 7 recruiting
- Recruiting
Diagnostic Centre
London, Others, W1G 7AF
- Recruiting
The Harley Street Clinic (THSC)
London, Other, W1G 8BJ
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
- Recruiting
Sarah Cannon Research Institute
London, W1G 6AD
- Recruiting
Radiology
London, W1G 8PP
- Recruiting
Pharmacy: Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
France6 sites, 6 recruiting
- Recruiting
Hôpital Saint André - CHU Bordeaux
Bordeaux, 33075
- Recruiting
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200
- Recruiting
Institut Curie
Paris, 75005
- Recruiting
lnstitut Curie Pharmacy
Paris, 75005
- Recruiting
Gustave Roussy Institute - Service pharmacie
Villejuif, 94805
- Recruiting
Gustave Roussy Institute
Villejuif, 94805
Spain6 sites, 6 recruiting
- Recruiting
CETIR Viladomat
Barcelona, Other, 08029
- Recruiting
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
Barcelona, Other, 08908
- Recruiting
Hospital Quiron Salud Barcelona
Barcelona, 08023
- Recruiting
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
Barcelona, 08023
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, 28050
China4 sites, 4 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
Beijing Friendship hospital, Capital Medical University
Beijing
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Italy4 sites, 4 recruiting
- Recruiting
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
Bologna, 40138
- Recruiting
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
Milan, Milan, 20141
- Recruiting
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
Verona, Other, 37134
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
Verona, Veneto, 37134
Canada3 sites, 3 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
- Recruiting
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Germany3 sites, 3 recruiting
- Recruiting
Charite Comprehensive Cancer Center
Berlin, 10117
- Recruiting
Charite Universitatsmedizin Berlin
Berlin, 12200
- Recruiting
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
Berlin, 13353
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
Netherlands1 site, 1 recruiting
- Recruiting
The Netherlands Cancer Institute
Amsterdam, 1066 CX
About this study
Official title: 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Gastric Cancer, Endometrial Cancer
- Being tested
- PF-08046054, pembrolizumab
- Keywords
- Non-small cell lung cancer, NSCLC, Head and neck squamous cell carcinoma, HNSCC, Triple Negative Breast Cancer, TNBC, Gastric cancer, Seattle Genetics, HCC, PDAC, Esophageal, Pfizer, Endometrial
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08046054Drug
Also called SGN-PDL1V
Given into the vein (IV; intravenously)
pembrolizumabDrug
Also called Keytruda
200 mg once every 3 weeks given into the vein (IV; intravenously)
| Study group | Role | What they receive |
|---|---|---|
| PF-08046054 Monotherapy | Experimental | PF-08046054 monotherapy Receives: Drug: PF-08046054 |
| PF-08046054 Combination Therapy | Experimental | PF-08046054 + pembrolizumab Receives: Drug: PF-08046054; Drug: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through approximately 90 days after last study treatment; up to 3 years
Number of participants with laboratory abnormalities
Measured: Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Measured: Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Measured: 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
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.
Measured: Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
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.
Measured: Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
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.
Measured: Up to approximately 3 years
Overall survival (OS)
The time from the start of study treatment to death due to any cause.
Measured: Up to approximately 3 years
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
To be summarized using descriptive statistics
Measured: Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Measured: Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Measured: Through 30-37 days after last study treatment; up to approximately 3 years
Incidence of anti-drug antibodies (ADAs)
To be summarized using descriptive statistics
Measured: Through 30-37 days after last study treatment; up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start25 Oct 2022
- Primary completion5 Jan 2028 (estimated)
- Study completion4 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 714 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208762
- Sponsor's protocol ID
- SGNPDL1V-001
- Other IDs
- C5851001, 2023-506604-18-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.