RecruitingPhase 1NCT05208762

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

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

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

714 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Endometrial Cancer Hepatocellular Carcinoma Carcinoma, Non-Small Cell Lung Esophageal Squamous Cell Carcinoma Triple Negative Breast Neoplasms Pancreatic Adenocarcinoma Squamous Cell Carcinoma of the Head and Neck

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PF-08046054 (also known as SGN-PDL1V) for people with advanced solid tumors. The drug is an antibody-drug conjugate — it combines an immune-targeting molecule that finds cancer cells with a powerful chemotherapy payload to destroy them. **You may be eligible if...** - You have advanced or metastatic cancer of one of these types: non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, triple negative breast cancer, pancreatic cancer, liver cancer, stomach cancer, or endometrial cancer - Your cancer has stopped responding to standard treatments - Your tumor has been tested for PD-L1 expression - You are generally in good physical condition (ECOG score of 0 or 1) **You may NOT be eligible if...** - You have had another cancer in the past 3 years - You have active brain metastases (though treated, stable brain metastases may be acceptable) - You have previously received an MMAE-containing drug - You have pre-existing nerve damage (neuropathy) of grade 2 or higher Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-08046054

Given into the vein (IV; intravenously)

DRUGpembrolizumab

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

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

View Full Details on ClinicalTrials.gov

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NCT05208762

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