NCT07519655 Phase 1 Study of PF-08046033 in Advanced Solid Tumors
| NCT ID | NCT07519655 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pfizer |
| Condition | Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2026-04-08 with a primary completion date of 2028-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07519655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07519655 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07519655 currently recruiting?
Yes, NCT07519655 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07519655 trial being conducted?
This trial is being conducted at Denver, United States, Denver, United States, New Haven, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT07519655 clinical trial?
NCT07519655 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 250 participants.