Phase 1 of PF-08046033 for advanced non-small-cell lung cancer, esophageal squamous cell cancer, and cutaneous melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Presbyterian/St Lukes Medical Center
  Denver, Colorado, United States Recruiting
• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• Smilow Cancer Hospital - Yale New Haven Health
  New Haven, Connecticut, United States Recruiting
• Yale - New Haven Hospital - Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Smilow Cancer Hospital Phase 1 Unit
  New Haven, Connecticut, United States Recruiting
• Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
  New Haven, Connecticut, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.