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PF-08046876 for people with advanced solid tumors

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

PHASE1 · Pfizer · NCT07090499

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

PhasePHASE1
Study typeInterventional
Enrollment310 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer (industry)
Drugs / interventionssacituzumab, trastuzumab
Locations28 sites (Duarte, California and 27 other locations)
Trial IDNCT07090499 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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
* 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

Where this trial is running

Duarte, California and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced/Metastatic Solid Tumors, Bladder Cancer, Urothelial Carcinoma, Advanced Non-Small Cell Lung Cancer, Carcinoma, Non Small Cell Lung, Carcinoma, Squamous Cell of Head and Neck, Head and Neck Cancer, Esophageal Cancer

Last reviewed 2026-05-15 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.