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:
202552000000
EU Trial (CTIS) Number:
2025-521729-33-00
Study Contact Information:
N/A
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.
  • Solid Tumor
  • Bladder
  • Urinary tract
  • Non-Small Cell Lung Cancer
  • Head & Neck
  • Esophageal
  • Gastroesophageal
  • Pancreas
    • 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.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Part 1 Dose Escalation
    • Read More
  • Drug: Different groups of participants will receive different doses and/or schedules of the study drug
  • Drug: Drug: PF-08046876
  • Drug: Intravenous administration
  • Drug: EXPERIMENTAL: Part 2 Dose Expansion
  • Drug: Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
  • Drug: EXPERIMENTAL: Part 2 Dose Optimization
  • Drug: Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    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
    Solid Tumor
    Bladder
    Urinary tract
    Non-Small Cell Lung Cancer
    Head & Neck
    Esophageal
    Gastroesophageal
    Pancreas