Recruiting NCT07090499
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PF-08046876.
- Who it may be relevant to
- Registry conditions: Advanced/Metastatic Solid Tumors, Bladder Cancer, Urothelial Carcinoma, Advanced Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Puerto Rico, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.
Overview
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.
Interventions
- Drug PF-08046876
Intravenous administration
Primary outcome measures
- Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation [Time frame: 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 [Time frame: Baseline to end of DLT evaluation period]
- Part 1: Recommended Monotherapy Dose for Expansion [Time frame: Baseline to 30 days post last study drug administration]
- Part 2: Recommended Phase 2 Dose [Time frame: Baseline to 30 days post last study drug administration]
Secondary outcome measures (10)
- Objective Response Rate (ORR) [Time frame: 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) [Time frame: From the date of the first objective response to the date of disease progression or death (approximately 2 years)]
- Progression Free Survival (PFS) [Time frame: From Baseline to date of first disease progression or death (approximately 2 Years)]
- Overall Survival (OS) [Time frame: From baseline to up to 3 years]
- Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax) [Time frame: Baseline to approximately 30 days after last dose of study drug]
- PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time frame: Baseline to approximately 30 days after last dose of study drug]
- PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) [Time frame: Baseline to approximately 30 days after last dose of study drug]
- Incidence of Anti-Drug Antibody (ADA) [Time frame: Baseline to approximately 30 days after last dose of study drug]
- Incidence of Neutralizing Antibodies (NAb) [Time frame: Baseline to approximately 30 days after last dose of study drug]
- Percent change of immune cells within tumors based on multiplex immunofluorescence [Time frame: Baseline through 4-7 weeks after first dose of study drug]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- City of Hope National Medical Center — Duarte
- City of Hope at Irvine Lennar — Irvine
- Ronald Reagan UCLA Medical Center — Los Angeles
- UCLA Department of Medicine-Hematology/Oncology — Los Angeles
- Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica
- UCLA Hematology/Oncology - Santa Monica — Santa Monica
- Smilow Cancer Hospital - Yale New Haven Health — New Haven
- Yale - New Haven Hospital - Yale Cancer Center — New Haven
- … and 13 more centers
Canada · 3 centers
- Princess Margaret Cancer Centre — Toronto
- Princess Margaret Cancer Centre — Toronto
- McGill University Health Centre — Montreal
Spain · 3 centers
- Hospital Universitari Vall d'Hebron — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Fundación Jiménez Díaz — Madrid
United Kingdom · 2 centers
- Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London — London
- The Christie NHS Foundation Trust — Manchester
Puerto Rico · 1 center
- Pan American Center for Oncology Trials, LLC — Rio Piedras
Identifiers
NCT: NCT07090499 · C5951001 · 2025-521729-33-00