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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07090499

Registry updated: 2026-10-13
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Description

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. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.

Interventions

  • PF-08046876 (Drug)
    Intravenous administration
  • Pembrolizumab (Combination product)
    Intravenous administration
  • Cisplatin (Combination product)
    Intravenous administration
  • Carboplatin (Combination product)
    Intravenous administration

Eligibility criteria

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 * Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group * 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 * Part 3: Meet contraindications of combination products per protocol and/or local labels

Conditions

Advanced/Metastatic Solid Tumors Bladder Cancer Urothelial Carcinoma Advanced Non-Small Cell Lung Cancer Carcinoma, Non Small Cell Lung Carcinoma, Squamous Cell of Head and Neck Head and Neck Cancer Esophageal Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Squamous Cell Carcinoma Esophageal Adenocarcinoma Pancreatic Adenocarcinoma Pancreatic Cancer

Locations

  • City of Hope National Medical Center — Duarte, California, United States
  • City of Hope at Irvine Lennar — Irvine, California, United States
  • Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
  • UCLA Department of Medicine-Hematology/Oncology — Los Angeles, California, United States
  • Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
  • UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
  • Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
  • Yale - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
  • Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States
  • Sarah Cannon Research Institute - Pharmacy — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • The University of Texas MD Anderson Cancer Center - Conroe — Conroe, Texas, United States
  • University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - West Houston — Houston, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - League City — League City, Texas, United States
  • NEXT Oncology — San Antonio, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - Sugar Land — Sugar Land, Texas, United States
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • McGill University Health Centre — Montreal, Quebec, Canada
  • Hunan Cancer Hospital — Changsha, Hunan, China
  • Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital Universitario 12 de Octubre — Madrid, Madrid, Comunidad de, Spain
  • Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
  • Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record