Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05208762

PHASE1

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

714

Start Date

2022-10-25

Completion Date

2029-01-04

Last Updated

2026-02-23

Healthy Volunteers

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 Pancreatic Adenocarcinoma Hepatocellular Carcinoma

Interventions

DRUG

PF-08046054

Given into the vein (IV; intravenously)

DRUG

pembrolizumab

200 mg once every 3 weeks given into the vein (IV; intravenously)

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.

Locations (61)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California, Davis Medical Center

Sacramento, California, United States

University of Iowa

Iowa City, Iowa, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Karmanos Cancer Institute

Farmington Hills, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, United States

UT Southwestern Medical Center - Redbird

Dallas, Texas, United States

Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital

Dallas, Texas, United States

University Of Texas Southwestern Medical Center

Dallas, Texas, United States

UT Southwestern - Simmons Cancer Center - Fort Worth

Fort Worth, Texas, United States

The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

Houston, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

UT Southwestern - Simmons Cancer Center - Richardson/Plano

Richardson, Texas, United States

NEXT Virginia, LLC

San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

Institut Jules Bordet

Anderlecht, Belgium

University Health Network

Toronto, Ontario, Canada

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Hôpital Saint André - CHU Bordeaux

Bordeaux, France

Clinique Ambroise Pare

Neuilly-sur-Seine, France

lnstitut Curie Pharmacy

Paris, France

Institut Curie

Paris, France

Gustave Roussy Institute - Service pharmacie

Villejuif, France

Charite Comprehensive Cancer Center

Berlin, Germany

Charite Universitatsmedizin Berlin

Berlin, Germany

Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum

Berlin, Germany

Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

Milan, Milan, Italy

Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi

Verona, Other, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi

Verona, Veneto, Italy

UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, Italy

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan

The Netherlands Cancer Institute

Amsterdam, Netherlands

CETIR Viladomat

Barcelona, Other, Spain

Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)

Barcelona, Other, Spain

Hospital Quiron Salud Barcelona

Barcelona, Spain

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

Madrid, Spain

Diagnostic Centre

London, Others, United Kingdom

The Harley Street Clinic (THSC)

London, Other, United Kingdom

Pharmacy: Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

Radiology

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)