NCT07519655RecruitingPhase 1
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- 8 Apr 2026
- Primary completion date
- 14 Jul 2028
- Lead sponsor
- Pfizer
- Diseases
- Melanoma, Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT07519655
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 250
- From 8 Apr 2026 to the primary completion date, 14 Jul 2028
- 20 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to GPNMB-targeted therapy.
Other illness
- Untreated clinically significant thromboembolic disease.
- Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.
Lab values
- Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
Other
- Participants with known clinically active central nervous system (CNS) metastases.
- Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Oncopole Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Hospital Oncologico Dr. Isaac Gonzalez-Martinez Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials LLC Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Recruiting |
| Sarah Cannon Research Institute at HealthONE Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Presbyterian/St Lukes Medical Center Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Inova Schar Cancer Infusion Pharmacy Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Inova Schar Cancer Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Sarah Cannon Research Institute- Pharmacy Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Smilow Cancer Hospital - Yale New Haven Health Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Yale - New Haven Hospital - Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Smilow Cancer Hospital Phase 1 Unit Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Smilow Cancer Hospital - Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.