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A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
NCT05208762 · Seagen Inc.
In plain English
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Official title
A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
About this study
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.
Eligibility criteria
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 design
Enrollment target: 714 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-10-25
Estimated completion: 2029-01-04
Last updated: 2026-02-23
Interventions
Drug: PF-08046054Drug: pembrolizumab
Primary outcomes
- • Number of participants with adverse events (AEs) (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)
Sponsor
Seagen, a wholly owned subsidiary of Pfizer · industry
Contacts & investigators
ContactSeagen Pfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (61)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS PharmacyRecruiting
Birmingham, Alabama, United States
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Chao Family Comprehensive Cancer Center and Ambulatory CareRecruiting
Irvine, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
University of California Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
University of California, Davis Medical CenterRecruiting
Sacramento, California, United States
University of IowaRecruiting
Iowa City, Iowa, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Karmanos Cancer InstituteRecruiting
Farmington Hills, Michigan, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center - Simmons Cancer CenterRecruiting
Dallas, Texas, United States
UT Southwestern Medical Center - RedbirdRecruiting
Dallas, Texas, United States
Univ. of TX Southwestern Medical Center - Zale Lipshy University HospitalRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical Center - William P. Clements, Jr., University HospitalRecruiting
Dallas, Texas, United States
University Of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
UT Southwestern - Simmons Cancer Center - Fort WorthRecruiting
Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center Investigational Pharmacy ServicesRecruiting
Houston, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
UT Southwestern - Simmons Cancer Center - Richardson/PlanoRecruiting
Richardson, Texas, United States
NEXT Virginia, LLCRecruiting
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLCRecruiting
San Antonio, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Institut Jules BordetRecruiting
Anderlecht, Belgium
University Health NetworkRecruiting
Toronto, Ontario, Canada
University Health Network, Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada
McGill University Health CentreRecruiting
Montreal, Quebec, Canada
Beijing Friendship Hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital UniversityRecruiting
Beijing, Beijing Municipality, China
Shanghai East HospitalRecruiting
Shanghai, Shanghai Municipality, China
Hôpital Saint André - CHU BordeauxRecruiting
Bordeaux, France
Clinique Ambroise PareRecruiting
Neuilly-sur-Seine, France
lnstitut Curie PharmacyRecruiting
Paris, France
Institut CurieRecruiting
Paris, France
Gustave Roussy Institute - Service pharmacieRecruiting
Villejuif, France
Charite Comprehensive Cancer CenterRecruiting
Berlin, Germany
Charite Universitatsmedizin BerlinRecruiting
Berlin, Germany
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow KlinkumRecruiting
Berlin, Germany
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di OncologiaRecruiting
Milan, Milan, Italy
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B RossiRecruiting
Verona, Other, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B RossiRecruiting
Verona, Veneto, Italy
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria BolognaRecruiting
Bologna, Italy
National Cancer Center Hospital EastRecruiting
Kashiwa, Chiba, Japan
Shizuoka Cancer CenterRecruiting
Nagaizumi-cho, Shizuoka, Japan
The Netherlands Cancer InstituteRecruiting
Amsterdam, Netherlands
CETIR ViladomatRecruiting
Barcelona, Other, Spain
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)Recruiting
Barcelona, Other, Spain
Hospital Quiron Salud BarcelonaRecruiting
Barcelona, Spain
NEXT Oncology Barcelona - IOB - Hospital Quironsalud BarcelonaRecruiting
Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
START Madrid - CIOCC - Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
Diagnostic CentreRecruiting
London, Others, United Kingdom
The Harley Street Clinic (THSC)Recruiting
London, Other, United Kingdom
Pharmacy: Royal Marsden HospitalRecruiting
Sutton, Surrey, United Kingdom
Royal Marsden HospitalRecruiting
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
London, United Kingdom
Sarah Cannon Research InstituteRecruiting
London, United Kingdom
RadiologyRecruiting
London, United Kingdom