Actively Recruiting
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Led by Pfizer · Updated on 2026-04-23
250
Participants Needed
6
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed metastatic or unresectable locally advanced non-small cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma.
- Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or have received 1-2 prior systemic therapies (Part 2).
- Participants must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
You will not qualify if you...
- Participants with known clinically active central nervous system metastases.
- Participants with pre-existing neuropathy of Grade 2 or higher per NCI CTCAE version 5.0.
- Participants with uncontrolled diabetes mellitus with hemoglobin A1C equal or greater than 10.0%.
- Participants with untreated clinically significant thromboembolic disease.
- Participants who have previously received GPNMB-targeted therapy.
- Participants with known or suspected hypersensitivity to any component or excipient in the study drug formulation.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Presbyterian/St Lukes Medical Center
Denver, Colorado, United States, 80218
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
5
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
6
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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