RecruitingPhase 1NCT07519655
Official study title

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPF-08046033

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Pfizer
Interventions being studied
Drug: PF-08046033
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Presbyterian/St Lukes Medical CenterDenver, Colorado
  • Sarah Cannon Research Institute at HealthONEDenver, Colorado
  • Smilow Cancer Hospital - Yale New Haven HealthNew Haven, Connecticut
  • Yale - New Haven Hospital - Yale Cancer CenterNew Haven, Connecticut
  • Smilow Cancer Hospital Phase 1 UnitNew Haven, Connecticut
  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOPNew Haven, Connecticut
  • Smilow Cancer Hospital - TrumbullTrumbull, Connecticut
  • Sarah Cannon Research Institute- PharmacyNashville, Tennessee
  • SCRI Oncology PartnersNashville, Tennessee
  • Inova Schar Cancer Infusion PharmacyFairfax, Virginia
  • Inova Schar CancerFairfax, Virginia
  • Oncopole Claudius RegaudToulouse

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2026. Always confirm current availability with the study team.

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