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

RECRUITINGPhase 1Sponsored by Pfizer
Actively Recruiting
PhasePhase 1
SponsorPfizer
Started2025-08-20
Est. completion2028-07-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations11 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions15

Advanced Non-Small Cell Lung CancerAdvanced/Metastatic Solid TumorsBladder CancerCancerCarcinoma, Non-Small-Cell LungCarcinoma, Squamous Cell of Head and NeckEsophageal AdenocarcinomaEsophageal CancerEsophageal Squamous Cell CarcinomaGastroesophageal Junction Adenocarcinoma

Locations11 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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