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NCT07090499PHASE1Recruiting

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

Pfizer

Start Date

8/20/2025

Completion Date

7/8/2029

Summary

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 years of age or older * Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas * Measurable disease * ECOG Performance status 0-1 * Part 1: progression or relapse following standard treatments * Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting * Resolution of acute effects of prior anticancer therapy to baseline or Grade 1 * Consent to submit required pre-treatment tumor tissue as medically feasible Exclusion criteria: * Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan ) * Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion * Pulmonary disease meeting protocol exclusion * Other unacceptable abnormalities as defined by protocol

Interventions

DRUG

PF-08046876

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Conditions

Advanced/Metastatic Solid TumorsBladder CancerUrothelial CarcinomaAdvanced Non-Small Cell Lung CancerCarcinoma, Non Small Cell LungCarcinoma, Squamous Cell of Head and NeckHead and Neck CancerEsophageal CancerGastroesophageal Junction AdenocarcinomaEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaPancreatic AdenocarcinomaPancreatic Cancer

Locations

City of Hope National Medical Center

Duarte, California 91010

United States

City of Hope at Irvine Lennar

Irvine, California 92618

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California 90095

United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California 90404

United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California 90404

United States

Smilow Cancer Hospital - Yale New Haven Health

New Haven, Connecticut 06510

United States

Yale - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut 06510

United States

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut 06511

United States

Smilow Cancer Hospital - Trumbull

Trumbull, Connecticut 06611

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute - Chestnut Hill

Newton, Massachusetts 02467

United States

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee 37203

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

The University of Texas MD Anderson Cancer Center - Conroe

Conroe, Texas 77384

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

The University of Texas, MD Anderson Cancer Center - West Houston

Houston, Texas 77079

United States

The University of Texas, MD Anderson Cancer Center - League City

League City, Texas 77573

United States

NEXT Oncology

San Antonio, Texas 78229

United States

The University of Texas, MD Anderson Cancer Center - Sugar Land

Sugar Land, Texas 77478

United States

Princess Margaret Cancer Centre

Toronto, Ontario M5G 1Z5

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1

Canada

Pan American Center for Oncology Trials, LLC

Rio Piedras, 00935

Puerto Rico

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona] 08035

Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de 28041

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London

London, EC1A 7BE

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom