Phase 1 Study of PF-08046033 in Advanced Solid Tumors (NCT07519655)
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).
Location: Presbyterian/St Lukes Medical Center — Denver, Colorado
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with known clinically active central nervous system (CNS) metastases.
- Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
- Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
- Untreated clinically significant thromboembolic disease.
- Previous exposure to GPNMB-targeted therapy.
- Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Presbyterian/St Lukes Medical Center — Denver, Colorado
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado
- Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut
- Yale - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut
- Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP — New Haven, Connecticut
- Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut
- Sarah Cannon Research Institute- Pharmacy — Nashville, Tennessee
- SCRI Oncology Partners — Nashville, Tennessee
- Inova Schar Cancer Infusion Pharmacy — Fairfax, Virginia
- Inova Schar Cancer — Fairfax, Virginia
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez — Rio Piedras,
- Pan American Center for Oncology Trials, LLC — Rio Piedras,
- Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul]
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul]
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.