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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | sacituzumab, trastuzumab |
| Locations | 31 sites (Duarte, California and 30 other locations) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | July 8, 2028 |
| Study ends | July 8, 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07090499 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
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors
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.
-
Testing NEO212 for treating certain brain tumors and metastases
This study is testing a new treatment called NEO212 for people with certain types of brain tumors to see if it is safe and effective when combined with standard treatments.
-
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.
-
Using stereotactic body radiotherapy for patients with rare oligometastatic cancers
This study is testing if adding a special type of targeted radiation therapy to standard treatment can help people with rare cancers that have spread to a few places live longer and feel better.
-
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.
-
Evaluating the impact of MR-guided radiation therapy on cancer treatment outcomes
This study is testing how using a special type of radiation therapy with real-time imaging can improve treatment results and quality of life for adults with cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.