Phase 1 Study of PF-08046033 in Advanced Solid Tumors

April 20, 2026 updated by: Pfizer

A Phase 1 Study to Investigate PF-08046033 in Participants With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials, LLC
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Hospital Oncologico Dr. Isaac Gonzalez-Martinez
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian/St Lukes Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • SCRI Oncology Partners
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Sarah Cannon Research Institute- Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Cohort 1
Participants will receive PF-08046033 dose level 1 intravenously (IV).
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 2
Participants will receive PF-08046033 dose level 2 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 3
Participants will receive PF-08046033 dose level 3 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 4
Participants will receive PF-08046033 dose level 4 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 5
Participants will receive PF-08046033 dose level 5 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 6
Participants will receive PF-08046033 dose level 6 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 1: Cohort 7
Participants will receive PF-08046033 dose level 7 IV.
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)
PF-08046033: Specified dose IV on specified days
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 2: Cohort 3 (Cutaneous Melanoma)
PF-08046033: Specified dose IV on specified days
Drug: PF-08046033
Powder for solution for infusion.
Experimental: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)
PF-08046033: Specified dose IV on specified days
Drug: PF-08046033
Powder for solution for infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
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
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
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
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
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
From the first day through 30-37 days after the last study treatment, up to approximately 1 year
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
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years
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.
Up to 3 years
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, Up to approximately 1 year
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
From Cycle 1 Day 1 (each cycle is 21 days) until End of Treatment, , Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C5921001
  • GPS [GPNMB-AurS] (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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