Recruiting
Phase 1

PF-08046033

Sponsor:

Pfizer

Code:

NCT07519655

Conditions

Non-Small-Cell Lung

Esophageal Cancer

Cutaneous Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08046033

Study Details

Brief summary:

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

Non-Small-Cell Lung

Esophageal Cancer

Cutaneous Melanoma

Study ID

NCT07519655

Start date

Apr 8, 2026

Status verified date

Sep, 2026

Completion date

Jul 14, 2029

Anticipated

Primary completion date

Jul 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Cohort 1

Participants will receive PF-08046033 dose level 1 intravenously (IV).

experimental: Part 1: Cohort 2

Participants will receive PF-08046033 dose level 2 IV.

experimental: Part 1: Cohort 3

Participants will receive PF-08046033 dose level 3 IV.

experimental: Part 1: Cohort 4

Participants will receive PF-08046033 dose level 4 IV.

experimental: Part 1: Cohort 5

Participants will receive PF-08046033 dose level 5 IV.

experimental: Part 1: Cohort 6

Participants will receive PF-08046033 dose level 6 IV.

experimental: Part 1: Cohort 7

Participants will receive PF-08046033 dose level 7 IV.

experimental: Part 2: Cohort 1 Non-Small Cell Lung Cancer (NSCLC)

PF-08046033: Specified dose IV on specified days

experimental: Part 2: Cohort 2 Esophageal Squamous Cell Carcinoma (ESCC)

PF-08046033: Specified dose IV on specified days

experimental: Part 2: Cohort 3 (Cutaneous Melanoma)

PF-08046033: Specified dose IV on specified days

Interventions

PF-08046033

Powder for solution for infusion.

Primary outcome measure

  • 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, 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 ]
  • 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 ]
  • 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 ]
  • Recommended dose and schedule of PF-08046033 for expansion (RDE) [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Locations

Presbyterian/St Lukes Medical Center

Recruiting

Denver, Colorado, United States, 80218

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Smilow Cancer Hospital - Yale New Haven Health

Recruiting

New Haven, Connecticut, United States, 06510

Yale - New Haven Hospital - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Smilow Cancer Hospital Phase 1 Unit

Recruiting

New Haven, Connecticut, United States, 06511

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

Recruiting

New Haven, Connecticut, United States, 06511

Smilow Cancer Hospital - Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Sarah Cannon Research Institute- Pharmacy

Recruiting

Nashville, Tennessee, United States, 37203

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Inova Schar Cancer Infusion Pharmacy

Recruiting

Fairfax, Virginia, United States, 22031

Inova Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Lung cancer
  • Esophageal cancer
  • Melanoma
  • Antibody drug conjugate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.