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 drugs 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
Research Team
P
Pfizer CT.gov Call Center
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