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A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
NCT07090499 · Pfizer
In plain English
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Official title
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
About this study
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
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
Study design
Enrollment target: 310 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-20
Estimated completion: 2029-07-08
Last updated: 2026-04-07
Interventions
Drug: PF-08046876
Primary outcomes
- • Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation (Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first))
- • Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy (Baseline to end of DLT evaluation period)
- • Part 1: Recommended Monotherapy Dose for Expansion (Baseline to 30 days post last study drug administration)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (28)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope at Irvine LennarRecruiting
Irvine, California, United States
Ronald Reagan UCLA Medical CenterNot Yet Recruiting
Los Angeles, California, United States
UCLA Department of Medicine-Hematology/OncologyNot Yet Recruiting
Los Angeles, California, United States
Santa Monica UCLA Medical Center & Orthopaedic HospitalNot Yet Recruiting
Santa Monica, California, United States
UCLA Hematology/Oncology - Santa MonicaNot Yet Recruiting
Santa Monica, California, United States
Smilow Cancer Hospital - Yale New Haven HealthRecruiting
New Haven, Connecticut, United States
Yale - New Haven Hospital - Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 UnitRecruiting
New Haven, Connecticut, United States
Smilow Cancer Hospital - TrumbullRecruiting
Trumbull, Connecticut, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut HillRecruiting
Newton, Massachusetts, United States
Sarah Cannon Research Institute - PharmacyRecruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center - ConroeNot Yet Recruiting
Conroe, Texas, United States
University of Texas MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
The University of Texas, MD Anderson Cancer Center - West HoustonNot Yet Recruiting
Houston, Texas, United States
The University of Texas, MD Anderson Cancer Center - League CityNot Yet Recruiting
League City, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
The University of Texas, MD Anderson Cancer Center - Sugar LandNot Yet Recruiting
Sugar Land, Texas, United States
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Pan American Center for Oncology Trials, LLCRecruiting
Rio Piedras, Puerto Rico
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona [barcelona], Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Fundación Jiménez DíazRecruiting
Madrid, Spain
Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of LondonNot Yet Recruiting
London, United Kingdom
The Christie NHS Foundation TrustNot Yet Recruiting
Manchester, United Kingdom