A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Who is this study for? Patients with Carcinoma, Melanoma
What treatments are being studied? SGN-PDL1V
Status: Recruiting
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

∙ 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
University of Alabama at Birmingham, IDS Pharmacy
RECRUITING
Birmingham
California
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
University of California, Davis Medical Center
RECRUITING
Sacramento
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Karmanos Cancer Institute
RECRUITING
Farmington Hills
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Texas
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
NOT_YET_RECRUITING
Dallas
University Of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
University of Texas Southwestern Medical Center - Simmons Cancer Center
NOT_YET_RECRUITING
Dallas
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
NOT_YET_RECRUITING
Dallas
UT Southwestern Medical Center - Redbird
NOT_YET_RECRUITING
Dallas
UT Southwestern - Simmons Cancer Center - Fort Worth
NOT_YET_RECRUITING
Fort Worth
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
RECRUITING
Houston
UT Southwestern - Simmons Cancer Center - Richardson/Plano
NOT_YET_RECRUITING
Richardson
South Texas Accelerated Research Therapeutics, LLC
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Canada
McGill University Health Centre
RECRUITING
Montreal
University Health Network, Princess Margaret Hospital
RECRUITING
Toronto
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Shanghai East Hospital
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
France
Hôpital Saint André - CHU Bordeaux
RECRUITING
Bordeaux
Clinique Ambroise Pare
RECRUITING
Neuilly-sur-seine
Institut Curie
RECRUITING
Paris
lnstitut Curie Pharmacy
RECRUITING
Paris
Gustave Roussy Institute - Service pharmacie
RECRUITING
Villejuif
Germany
Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum
RECRUITING
Berlin
Charite Comprehensive Cancer Center
RECRUITING
Berlin
Charite Universitatsmedizin Berlin
RECRUITING
Berlin
Italy
UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna
RECRUITING
Bologna
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia
RECRUITING
Milan
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi
RECRUITING
Verona
Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi
RECRUITING
Verona
Japan
National Cancer Center Hospital East
RECRUITING
Kashiwa
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Netherlands
The Netherlands Cancer Institute
RECRUITING
Amsterdam
Spain
CETIR Viladomat
RECRUITING
Barcelona
Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)
RECRUITING
Barcelona
Hospital Quiron Salud Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona
RECRUITING
Barcelona
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
United Kingdom
Diagnostic Centre
RECRUITING
London
Radiology
RECRUITING
London
Sarah Cannon Research Institute
RECRUITING
London
The Harley Street Clinic (THSC)
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
Pharmacy: Royal Marsden Hospital
RECRUITING
Sutton
Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Seagen Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-10-25
Estimated Completion Date: 2028-04-08
Participants
Target number of participants: 315
Treatments
Experimental: PF-08046054 Monotherapy
PF-08046054 monotherapy
Experimental: PF-08046054 Combination Therapy
PF-08046054 + pembrolizumab
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov