Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Key facts
- Where
- Denver, Fairfax, Nashville, New Haven, and Trumbull, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- Presbyterian/St Lukes Medical CenterDenver, United StatesTaking people
- Sarah Cannon Research Institute at HealthONEDenver, United StatesTaking people
- Inova Schar CancerFairfax, United StatesTaking people
- Inova Schar Cancer Infusion PharmacyFairfax, United StatesTaking people
- Sarah Cannon Research Institute- PharmacyNashville, United StatesTaking people
- SCRI Oncology PartnersNashville, United StatesTaking people
- Smilow Cancer Hospital - Yale New Haven HealthNew Haven, United StatesTaking people
- Smilow Cancer Hospital Phase 1 UnitNew Haven, United StatesTaking people
- Yale - New Haven Hospital - Yale Cancer CenterNew Haven, United StatesTaking people
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOPNew Haven, United StatesTaking people
- Smilow Cancer Hospital - TrumbullTrumbull, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT07519655
- Record updated
- 5 November 2026
- Original description
This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.Read full original descriptionShow less
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.
The study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.
The study has two parts:
In the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.
Once a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.
Participants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.
Inclusion: Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma; Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2); Participants must have measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.
Exclusion: Previous exposure to GPNMB-targeted therapy; Untreated clinically significant thromboembolic disease; Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention; Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%; Participants with known clinically active central nervous system (CNS) metastases; Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.