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New hope for advanced cancers? pfizer launches early trial of PF-08046033

NCT ID NCT07519655

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This early-stage study tests a new medicine called PF-08046033 in adults with advanced lung, esophageal, or skin cancers that have spread or can't be removed. The main goal is to check safety and find the right dose. Researchers will also look for early signs that the drug may help control the cancer. About 250 people will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma lung neoplasm melanoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous melanoma Esophageal cancer Non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Oncologico Dr. Isaac Gonzalez-Martinez

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Inova Schar Cancer

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Inova Schar Cancer Infusion Pharmacy

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Pan American Center for Oncology Trials, LLC

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Presbyterian/St Lukes Medical Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

  • Sarah Cannon Research Institute at HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute- Pharmacy

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

  • Smilow Cancer Hospital - Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital - Yale New Haven Health

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Smilow Cancer Hospital Phase 1 Unit

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Yale - New Haven Hospital - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP

    RECRUITING

    New Haven, Connecticut, 06511, United States

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Other studies related to the condition(s) this trial covers.