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NCT07519655RecruitingPhase 1

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
250 (estimated)
First submitted
30 Mar 2026
Start date
8 Apr 2026
Primary completion date
14 Jul 2028
Lead sponsor
Pfizer
NCT number
NCT07519655

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 250
  • From 8 Apr 2026 to the primary completion date, 14 Jul 2028
  • 20 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous exposure to GPNMB-targeted therapy.

Other illness

  • Untreated clinically significant thromboembolic disease.
  • Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.

Lab values

  • Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.

Other

  • Participants with known clinically active central nervous system (CNS) metastases.
  • Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Oncopole Claudius Regaud
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ToulouseFranceRecruiting
Gustave Roussy
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VillejuifFranceRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Coordinator of this site? Confirm its status
Rio PiedrasPuerto RicoRecruiting
Pan American Center for Oncology Trials LLC
Coordinator of this site? Confirm its status
Rio PiedrasPuerto RicoRecruiting
Sarah Cannon Research Institute at HealthONE
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DenverUnited StatesRecruiting
Presbyterian/St Lukes Medical Center
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DenverUnited StatesRecruiting
Inova Schar Cancer Infusion Pharmacy
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FairfaxUnited StatesRecruiting
Inova Schar Cancer
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FairfaxUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Sarah Cannon Research Institute- Pharmacy
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NashvilleUnited StatesRecruiting
Smilow Cancer Hospital - Yale New Haven Health
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New HavenUnited StatesRecruiting
Yale - New Haven Hospital - Yale Cancer Center
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New HavenUnited StatesRecruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
Smilow Cancer Hospital Phase 1 Unit
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New HavenUnited StatesRecruiting
Smilow Cancer Hospital - Trumbull
Coordinator of this site? Confirm its status
TrumbullUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.