A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
2 other identifiers
interventional
310
5 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2025
Longer than P75 for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
July 29, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 8, 2029
March 19, 2026
March 1, 2026
2.9 years
July 21, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy
Occurrence of DLTs as defined by the protocol
Baseline to end of DLT evaluation period
Part 1: Recommended Monotherapy Dose for Expansion
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
Baseline to 30 days post last study drug administration
Part 2: Recommended Phase 2 Dose
RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.
Baseline to 30 days post last study drug administration
Secondary Outcomes (10)
Objective Response Rate (ORR)
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of Response (DOR)
From the date of the first objective response to the date of disease progression or death (approximately 2 years)
Progression Free Survival (PFS)
From Baseline to date of first disease progression or death (approximately 2 Years)
Overall Survival (OS)
From baseline to up to 3 years
Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)
Baseline to approximately 30 days after last dose of study drug
- +5 more secondary outcomes
Study Arms (3)
Part 1 Dose Escalation
EXPERIMENTALDifferent groups of participants will receive different doses and/or schedules of the study drug
Part 2 Dose Optimization
EXPERIMENTALParticipants will be randomized to 2 dosing regimens deemed to be safe in Part 1
Part 2 Dose Expansion
EXPERIMENTALParticipants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Interventions
Intravenous administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )
- Other unacceptable abnormalities as defined by protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (28)
City of Hope National Medical Center
Duarte, California, 91010, United States
City of Hope at Irvine Lennar
Irvine, California, 92618, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California, 90095, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510, United States
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511, United States
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center - Conroe
Conroe, Texas, 77384, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079, United States
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, 77573, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, 77478, United States
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London
London, EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2025
First Posted
July 29, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
July 8, 2028
Study Completion (Estimated)
July 8, 2029
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.