Clinical trial Recruiting at 30 sites Phase 1 Interventional Ages 18 and up

PF-08046876 for people with advanced solid tumors

Official title: A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

Run by Pfizer · NCT07090499 · Data updated 2026-11-12

This trial tests a new antibody–drug conjugate called PF-08046876 given by IV in adults with advanced bladder, lung, head and neck, esophageal, or pancreatic cancers to see if it is safe and how it affects tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment540 (estimated)
SponsorPfizer
Industry-sponsored
Drugs / interventionssacituzumab, trastuzumab
Locations31 sites (Duarte, California and 30 other locations)
StatusRecruiting
StartedAugust 20, 2025
Main results expectedJuly 8, 2028
Study endsJuly 8, 2029
Registry record updatedNovember 5, 2026
Trial IDNCT07090499 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with measurable advanced or metastatic solid tumors of the bladder, lung, head and neck, esophagus, or pancreas, ECOG 0–1, who meet the prior-treatment requirements and can provide required tumor tissue are the intended participants.

Probably not a fit

Patients who previously received camptothecin-class ADCs, who have uncontrolled gastrointestinal obstruction or excluded pulmonary disease, or who do not meet organ-function or performance criteria are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PF-08046876 is an investigational antibody–drug conjugate that targets integrin beta‑6 and delivers a cytotoxic payload to cancer cells. This Phase 1, open-label study enrolls adults with advanced or metastatic solid tumors, including urothelial (bladder) and non–small cell lung cancers, to receive intravenous infusions of the study drug. The protocol uses dose-escalation cohorts and may test multiple dosing schedules to define safety, tolerability, and preliminary anti-tumor activity, and requires available pre-treatment tumor tissue when medically feasible. Early parts require prior progression after standard therapies while a later part limits prior systemic therapy in the advanced setting to two lines.

Why it matters

Potential benefit: If successful, PF-08046876 could provide a new targeted treatment that delivers chemotherapy directly to tumor cells and may shrink cancers that have stopped responding to standard options.

How similar studies have gone: Other antibody–drug conjugates have shown benefit in some solid tumors (for example, sacituzumab govitecan and trastuzumab deruxtecan), but targeting integrin beta‑6 with this payload is a newer approach with limited prior clinical data.

Who can join: the full rules

Show full inclusion / exclusion 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
* Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group
* 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
* Part 3: Meet contraindications of combination products per protocol and/or local labels

Where it's running

  • City of Hope National Medical Center
    Duarte, California, United States
    Recruiting
  • City of Hope at Irvine Lennar
    Irvine, California, United States
    Recruiting
  • Administrative Address: UCLA Hematology/Oncology
    Los Angeles, California, United States
    Recruiting
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, United States
    Recruiting
  • Santa Monica UCLA Medical Center & Orthopaedic Hospital
    Santa Monica, California, United States
    Recruiting
  • UCLA Hematology/Oncology - Santa Monica
    Santa Monica, California, United States
    Recruiting
Show 25 more locations
  • Smilow Cancer Hospital - Yale New Haven Health
    New Haven, Connecticut, United States
    Recruiting
  • Yale - New Haven Hospital - Yale Cancer Center
    New Haven, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Phase 1 Unit
    New Haven, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital - Trumbull
    Trumbull, Connecticut, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute - Chestnut Hill
    Newton, Massachusetts, United States
    Recruiting
  • Sarah Cannon Research Institute - Pharmacy
    Nashville, Tennessee, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center - Conroe
    Conroe, Texas, United States
    Recruiting
  • University of Texas MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • The University of Texas, MD Anderson Cancer Center - West Houston
    Houston, Texas, United States
    Recruiting
  • The University of Texas, MD Anderson Cancer Center - League City
    League City, Texas, United States
    Recruiting
  • NEXT Oncology
    San Antonio, Texas, United States
    Recruiting
  • The University of Texas, MD Anderson Cancer Center - Sugar Land
    Sugar Land, Texas, United States
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting
  • McGill University Health Centre
    Montreal, Quebec, Canada
    Recruiting
  • Pan American Center for Oncology Trials, LLC
    Rio Piedras, Puerto Rico
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona [barcelona], Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Comunidad de, Spain
    Recruiting
  • Hospital Universitario Fundación Jiménez Díaz
    Madrid, Spain
    Recruiting
  • Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London
    London, United Kingdom
    Recruiting
  • The Christie NHS Foundation Trust
    Manchester, United Kingdom
    Recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan, China
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

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  • Validation of a blood test for early cancer detection and monitoring

    This study is testing a blood test to see if it can help find different types of cancer early and monitor patients after treatment.

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  • Testing a new drug for advanced solid tumors

    This study is testing a new drug called sigvotatug vedotin to see if it can safely help people with advanced solid tumors, both on its own and with other treatments.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.