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NCT05208762PHASE1Recruiting

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

Seagen, a wholly owned subsidiary of Pfizer

Start Date

10/25/2022

Completion Date

1/4/2029

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

PF-08046054

DRUG

pembrolizumab

Interested in This Trial?

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Conditions

Carcinoma, Non-Small-Cell LungSquamous Cell Carcinoma of the Head and NeckEsophageal Squamous Cell CarcinomaTriple Negative Breast NeoplasmsGastric CancerEndometrial CancerPancreatic AdenocarcinomaHepatocellular Carcinoma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama 35249

United States

University of Alabama at Birmingham

Birmingham, Alabama 35249

United States

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California 92612

United States

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

University of California, Davis Medical Center

Sacramento, California 95817

United States

University of Iowa

Iowa City, Iowa 52242

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Karmanos Cancer Institute

Farmington Hills, Michigan 48334

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas 75235

United States

UT Southwestern Medical Center - Redbird

Dallas, Texas 75237

United States

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

Dallas, Texas 75390

United States

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

Dallas, Texas 75390

United States

University Of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

UT Southwestern - Simmons Cancer Center - Fort Worth

Fort Worth, Texas 76104

United States

The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

Houston, Texas 77030

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

UT Southwestern - Simmons Cancer Center - Richardson/Plano

Richardson, Texas 75080

United States

NEXT Virginia, LLC

San Antonio, Texas 78229

United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas 78229

United States

START Mountain Region

West Valley City, Utah 84119

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Institut Jules Bordet

Anderlecht, 1070

Belgium

University Health Network

Toronto, Ontario M5G 2C4

Canada

University Health Network, Princess Margaret Hospital

Toronto, Ontario M5G 2M9

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality 100050

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Shanghai East Hospital

Shanghai, Shanghai Municipality 200123

China

Beijing Friendship hospital, Capital Medical University

Beijing,

China

Hôpital Saint André - CHU Bordeaux

Bordeaux, 33075

France

Clinique Ambroise Pare

Neuilly-sur-Seine, 92200

France

Institut Curie

Paris, 75005

France

lnstitut Curie Pharmacy

Paris, 75005

France

Gustave Roussy Institute - Service pharmacie

Villejuif, 94805

France

Gustave Roussy Institute

Villejuif, 94805

France

Charite Comprehensive Cancer Center

Berlin, 10117

Germany

Charite Universitatsmedizin Berlin

Berlin, 12200

Germany

Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum

Berlin, 13353

Germany

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

Milan, Milan 20141

Italy

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

Verona, Other 37134

Italy

Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi

Verona, Veneto 37134

Italy

UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

Bologna, 40138

Italy

National Cancer Center Hospital East

Kashiwa, Chiba 277-8577

Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka 411-8777

Japan

The Netherlands Cancer Institute

Amsterdam, 1066 CX

Netherlands

CETIR Viladomat

Barcelona, Other 08029

Spain

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

Barcelona, Other 08908

Spain

Hospital Quiron Salud Barcelona

Barcelona, 08023

Spain

NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

Barcelona, 08023

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Diagnostic Centre

London, Others W1G 7AF

United Kingdom

The Harley Street Clinic (THSC)

London, Other W1G 8BJ

United Kingdom

Pharmacy: Royal Marsden Hospital

Sutton, Surrey SM2 5PT

United Kingdom

Royal Marsden Hospital

Sutton, Surrey SM2 5PT

United Kingdom

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ

United Kingdom

Sarah Cannon Research Institute

London, W1G 6AD

United Kingdom

Radiology

London, W1G 8PP

United Kingdom