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Recruiting Phase 1

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

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About this study

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.

Condition
Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
Tested
PF-08046033
Sponsor
Pfizer

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Non-Small-Cell Lung, Esophageal Cancer, Cutaneous Melanoma
  • 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 6

  • 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.

Where

20 sites, 20 recruiting

Gustave Roussy

Villejuif, France

Recruiting

Hospital Oncologico Dr. Isaac Gonzalez-Martinez

Rio Piedras, Puerto Rico

Recruiting

Pan American Center for Oncology Trials, LLC

Rio Piedras, Puerto Rico

Recruiting

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Recruiting

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Recruiting

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Recruiting

and 14 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.