Actively Recruiting
A Phase 1 Open-label Study to Investigate PF-08046876 in Adults With Advanced Solid Tumors
Led by Pfizer · Updated on 2026-04-07
310
Participants Needed
28
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of an investigational anticancer drug called PF-08046876 in adults with advanced cancers of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is a type of antibody drug conjugate (ADC) designed to attach to cancer cells and kill them. This phase 1 open-label study aims to explore different doses and schedules of this study drug to better understand its impact and safety in these advanced solid tumors. Participants will receive PF-08046876 through an intravenous infusion. The study has multiple parts: the first part involves groups receiving varying doses and treatment schedules to find safe regimens. In the second part, participants will be randomized to two dosing schedules found safe in the first part or assigned to tumor-specific groups receiving one of these safe regimens. This design helps optimize dosing for further study. During the trial, participants will be closely monitored for treatment-related side effects, including dose-limiting toxicities and adverse events from the start of treatment up to 30 days after the last dose or new cancer therapy. Researchers will assess tumor response, progression-free survival, overall survival, and drug levels in the blood over about two to three years. Tumor tissue and immune cells will be examined before and after treatment to understand the drug's effects. The study may last several years depending on participant involvement and treatment response.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas
- Measurable disease present
- ECOG Performance status of 0 or 1
- For Part 1: progression or relapse after standard treatments
- For Part 2: no more than 2 prior lines of systemic therapy in the advanced setting
- Acute effects of prior anticancer therapy resolved to baseline or Grade 1
- Willingness to provide pre-treatment tumor tissue as medically feasible
You will not qualify if you...
- Prior treatment with an antibody drug conjugate containing a camptothecin-class payload (e.g., sacituzumab govitecan, trastuzumab deruxtecan)
- Active anorexia, nausea, vomiting, or signs of intestinal obstruction that meet exclusion criteria
- Pulmonary disease meeting protocol exclusion criteria
- Other unacceptable abnormalities as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days after last dose or start of new anticancer therapy
Participants receive intravenous doses of the study drug PF-08046876 in varying schedules and doses depending on trial part and group assignment.
Multiple visits for dosing and assessments throughout treatment
Duration - Up to 3 years
Participants are monitored for safety and response up to 3 years following treatment completion.
Regular follow-up visits during monitoring period
Trial Site Locations
Total: 28 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
3
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, United States, 90095
Not Yet Recruiting
5
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States, 90404
Not Yet Recruiting
6
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
Not Yet Recruiting
7
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States, 06511
Actively Recruiting
10
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
11
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States, 02467
Actively Recruiting
14
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
The University of Texas MD Anderson Cancer Center - Conroe
Conroe, Texas, United States, 77384
Not Yet Recruiting
17
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
18
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, United States, 77079
Not Yet Recruiting
19
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, United States, 77573
Not Yet Recruiting
20
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
21
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, United States, 77478
Not Yet Recruiting
22
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
23
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
24
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain, 08035
Actively Recruiting
25
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain, 28041
Actively Recruiting
26
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
27
Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
28
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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