A Phase I Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

Study Identifier:
C5951001
CT.gov Identifier:
NCT07090499
EudraCT Identifier:
202552172933
EU Trial (CTIS) Number:
2025-521729-33-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Non-Small Cell Lung Cancer
Pancreas
Head & Neck
Digestive & Intestinal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • Inclusion Criteria:
  • 18 years of age or olderAdvanced cancer of the bladder, lung, head and neck, esophagus, or pancreasMeasurable diseaseECOG Performance status 0-1Part 1: progression or relapse following standard treatmentsPart 2: maximum of 2 prior lines of systemic therapy in the advanced settingPart 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy groupResolution of acute effects of prior anticancer therapy to baseline or Grade 1Consent to submit required pre-treatment tumor tissue as medically feasible
Exclusion criteria
  • 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 exclusionPulmonary disease meeting protocol exclusionOther unacceptable abnormalities as defined by protocolPart 3: Meet contraindications of combination products per protocol and/or local labels

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Bernard Doger de Speville
Status
Recruiting
Condition(s) Treated at Site
Bladder
Non-Small Cell Lung Cancer
Pancreas
Head & Neck
Digestive & Intestinal