Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 2 Esophageal Squamous Cell Carcinoma (ESCC)
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.

Recruiting Locations

Presbyterian/St Lukes Medical Center
Denver, Colorado 80218

Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218

Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee 37203

SCRI Oncology Partners
Nashville, Tennessee 37203

Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, Puerto Rico 00935

Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.