N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 ClinicalTrials.gov

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07519655

Registry updated: 2026-10-13
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

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. 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.

Interventions

  • PF-08046033 (Drug)
    Powder for solution for infusion.

Eligibility criteria

Inclusion Criteria: 1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma. 2. 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). 3. Participants must have measurable disease. 4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1. Exclusion Criteria: 1. Participants with known clinically active central nervous system (CNS) metastases. 2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0. 3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%. 4. Untreated clinically significant thromboembolic disease. 5. Previous exposure to GPNMB-targeted therapy. 6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.

Conditions

Non-Small-Cell Lung Esophageal Cancer Cutaneous Melanoma

Locations

  • Presbyterian/St Lukes Medical Center — Denver, Colorado, United States
  • Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
  • Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
  • Yale - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP — New Haven, Connecticut, United States
  • Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut, United States
  • Sarah Cannon Research Institute- Pharmacy — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Inova Schar Cancer Infusion Pharmacy — Fairfax, Virginia, United States
  • Inova Schar Cancer — Fairfax, Virginia, United States
  • Oncopole Claudius Regaud — Toulouse, France
  • Gustave Roussy — Villejuif, France
  • Hospital Oncologico Dr. Isaac Gonzalez-Martinez — Rio Piedras, Puerto Rico
  • Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record