NCT07519655From ClinicalTrials.govRecruiting

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors

Non-Small-Cell Lung
Esophageal Cancer
Cutaneous Melanoma

At a glance

Phase: Phase 1
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 250
Started: 8 April 2026
Main results due: 14 July 2028
Study sites: 20
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(20)

Presbyterian/St Lukes Medical Center
Denver, Colorado, United States
Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
Recruiting
Yale - New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
Recruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, United States
Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, United States
Recruiting
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Inova Schar Cancer Infusion Pharmacy
Fairfax, Virginia, United States
Recruiting
Inova Schar Cancer
Fairfax, Virginia, United States
Recruiting
Oncopole Claudius Regaud
Toulouse, France
Not yet recruiting
Gustave Roussy
Villejuif, France
Not yet 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
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Not yet recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Not yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Recruiting

Showing 20 of 20 sites. 16 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07519655. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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