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

NCT07090499

RecruitingPhase 1

Sponsor: Pfizer

Conditions: Advanced/Metastatic Solid Tumors, Bladder Cancer, Urothelial Carcinoma, Advanced Non-Small Cell Lung Cancer, Carcinoma, Non Small Cell Lung

Interventions: PF-08046876

Countries: United States, Canada, Puerto Rico, Spain, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
* 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
Locations (30)
  • Duarte, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Santa Monica, California, United States
  • Santa Monica, California, United States
  • New Haven, Connecticut, United States
  • New Haven, Connecticut, United States
  • New Haven, Connecticut, United States
  • Trumbull, Connecticut, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Newton, Massachusetts, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Conroe, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • League City, Texas, United States
  • San Antonio, Texas, United States
  • Sugar Land, Texas, United States
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Rio Piedras, Puerto Rico
  • Barcelona, Barcelona [barcelona], Spain
  • Madrid, Madrid, Comunidad de, Spain
  • Madrid, Spain
  • London, United Kingdom
  • Manchester, United Kingdom