Phase 1 of PF-08046033 for advanced non-small-cell lung cancer, esophageal squamous cell cancer, and cutaneous melanoma
A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors
This Phase 1 study will try the experimental antibody-drug conjugate PF-08046033 in adults whose non-small-cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma has progressed after standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 6 sites (Denver, Colorado and 5 other locations) |
| Trial ID | NCT07519655 on ClinicalTrials.gov |
What this trial studies
PF-08046033 is an antibody-drug conjugate being tested in adults with metastatic or unresectable non-small-cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma. The study begins with a dose-escalation phase to find a safe and tolerable dose and then opens expansion cohorts by tumor type to further define safety and early signs of anti-tumor activity. Key endpoints include safety, tolerability, pharmacokinetics, and preliminary tumor response. Eligible participants must have measurable disease and an ECOG performance status of 0–1.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed metastatic or unresectable non-small-cell lung cancer, esophageal squamous cell cancer, or cutaneous melanoma that has progressed after standard treatments, with measurable disease and ECOG 0–1.
Not a fit: Patients with active central nervous system metastases, significant pre-existing neuropathy (≥Grade 2), uncontrolled diabetes, prior GPNMB-targeted therapy, or known hypersensitivity to the drug formulation are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, PF-08046033 could offer a new treatment option that shrinks tumors or slows disease progression for patients who have exhausted standard therapies.
How similar studies have performed: Other antibody-drug conjugates have demonstrated anti-tumor activity in some cancers, but GPNMB-targeted therapies to date have shown mixed results and are still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Denver, Colorado and 5 other locations
- Presbyterian/St Lukes Medical Center — Denver, Colorado, United States (Recruiting)
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (Recruiting)
- Sarah Cannon Research Institute- Pharmacy — Nashville, Tennessee, United States (Not_yet_recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Not_yet_recruiting)
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez — Rio Piedras, Puerto Rico (Recruiting)
- Pan American Center for Oncology Trials, LLC — Rio Piedras, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.