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Phase 1 Study of PF-08046033 in Advanced Solid Tumors

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

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.

About the 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.

What is being tested

Sponsor: Pfizer · Participants: 250 · Started: Apr 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07519655

Locations in the U.S.

ColoradoPresbyterian/St Lukes Medical Center, Denver
Sarah Cannon Research Institute at HealthONE, Denver
ConnecticutSmilow Cancer Hospital - Yale New Haven Health, New Haven
Smilow Cancer Hospital Phase 1 Unit, New Haven
Yale - New Haven Hospital - Yale Cancer Center, New Haven
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP, New Haven
Smilow Cancer Hospital - Trumbull, Trumbull
TennesseeSCRI Oncology Partners, Nashville
Sarah Cannon Research Institute- Pharmacy, Nashville
VirginiaInova Schar Cancer, Fairfax
Inova Schar Cancer Infusion Pharmacy, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.