RecruitingRecruiting
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
NCT07519655 · Pfizer
In plain English
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Official title
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
About this study
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.
Eligibility criteria
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 target: 250 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-08
Estimated completion: 2029-07-14
Last updated: 2026-04-23
Interventions
Drug: PF-08046033
Primary outcomes
- • Type, incidence and severity of participants with 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 (From the first day through 30-37 days after the last study treatment, up to approximately 1 year)
- • Number of participants with dose modifications (From the first day through 30-37 days after the last study treatment, up to approximately 1 year)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (6)
Presbyterian/St Lukes Medical CenterRecruiting
Denver, Colorado, United States
Sarah Cannon Research Institute at HealthONERecruiting
Denver, Colorado, United States
Sarah Cannon Research Institute- PharmacyNot Yet Recruiting
Nashville, Tennessee, United States
SCRI Oncology PartnersNot Yet Recruiting
Nashville, Tennessee, United States
Hospital Oncologico Dr. Isaac Gonzalez-MartinezRecruiting
Rio Piedras, Puerto Rico
Pan American Center for Oncology Trials, LLCRecruiting
Rio Piedras, Puerto Rico