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NCT Number: NCT07519655

Phase 1 Study of PF-08046033 in Advanced Solid Tumors

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 information

Conditions

Non-Small-Cell Lung Cutaneous Melanoma Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Diseases Lung Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Oncologico Dr. Isaac Gonzalez-Martinez, Rio Piedras, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participants with known clinically active central nervous system (CNS) metastases.
  • Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.
  • Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.
  • Untreated clinically significant thromboembolic disease.
  • Previous exposure to GPNMB-targeted therapy.
  • Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.

Treatment and study plan

PF-08046033

Drug

Powder for solution for infusion.

Primary outcomes

  1. Type, incidence and severity of participants with adverse events (AEs)

    Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Type, incidence, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 5.0), seriousness, and relatedness of adverse events (AEs).

  2. Type, incidence, and severity of participants with laboratory abnormalities

    Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities

  3. Number of participants with dose modifications

    Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    Frequency of dose modifications (eg, dose delay and treatment discontinuations) due to AEs

  4. Incidence of dose-limiting toxicities (DLTs)

    Time frame: From the first day through 30-37 days after the last study treatment, up to approximately 1 year

    To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) of PF-08046033

  5. Recommended dose and schedule of PF-08046033 for expansion (RDE)

    Time frame: Up to 1 year

    RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

Secondary outcomes

  1. Objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator

    Time frame: Up to 3 years

    Objective response defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1, from the date of first dose until the date of the first documentation of PD, death, or start of new anticancer therapy, whichever occurs first.

  2. Duration of response (DOR) using RECIST v1.1 as assessed by investigator

    Time frame: Up to 3 years

    DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.

  3. Progression-free survival (PFS) using RECIST v1.1 as assessed by investigator

    Time frame: Up to 3 years

    Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.

  4. Overall survival (OS) using RECIST v1.1 as assessed by investigator

    Time frame: Up to 3 years

    Overall survival defined as the time from the date of randomization to the date of death due to any cause.

  5. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of PF-08046033

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year

    To characterize the PK of PF-08046033

  6. PK: Area under the concentration-time curve (AUC) of PF-08046033

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

    To characterize the PK of PF-08046033

  7. PK: Time to Maximum concentration (Tmax) of PF-08046033

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

    To characterize the PK of PF-08046033

  8. PK: Trough concentration (Ctrough) of PF-08046033

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

    To characterize the PK of PF-08046033

  9. PK: Terminal Elimination half-life (t1/2) of PF-08046033

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

  10. Incidence of antidrug antibodies (ADAs)

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

    To characterize the immunogenicity of PF-08046033

  11. Percent change of immune cells and PD-L1 expression based on immunohistochemistry

    Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year

    To evaluate the pharmacodynamic effects of PF-08046033 in tumor tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 9, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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