What is the Purpose of this Study?
This clinical trial is for adults with advanced melanoma or certain other types of solid tumors. The goal is to learn more about a new investigational drug called PF-08046031, including how safe it is, how it affects the body, and whether it may help treat cancer. PF-08046031 is an antibody-drug conjugate (ADC)—a type of targeted cancer therapy. It works in 2 parts. The antibody part is designed to find and attach to a protein which is found in high levels on the surface of certain cancer cells. Once the antibody binds to the cancer cell, it delivers a chemotherapy drug directly into the cell, aiming to kill the cancer while limiting damage to healthy cells. The study has 3 parts: Part 1 will focus on finding the best dose and schedule for giving PF-08046031, while also monitoring for side effects. Part 2 will continue testing the drug at the dose chosen in Part 1 to better understand its safety and how the body handles it. Part 3 will use the information from the first 2 parts to evaluate how well PF-08046031 works in treating certain cancers, including melanoma, non-small cell lung cancer (NSCLC), cancers that start in the mouth, throat, or voice box (head and neck cancers), and esophageal cancer. By participating in this study, patients will help researchers understand whether PF-08046031 could become a new treatment option for cancers that are difficult to treat with standard therapies.
Eligibility
- * Participants in Part 1 (dose escalation) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti programmed death-1 (PD 1)/programmed death-ligand 1 (PD L1) immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) and should have no appropriate standard therapy available at the time of enrollment in the judgment of the investigator.
- * Participants in Part 2 (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable cutaneous melanoma. They must have progressive disease following at least 1 prior anti PD 1/PD L1 immunotherapy containing regimen (either as monotherapy, or in combination with other checkpoint inhibitors or other therapies) but not more than 2 total prior lines of systemic therapy.
- * For Part 3 (dose expansion): Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from 1 of the following tumor types: cutaneous melanoma, NSCLC, HNSCC, esophageal cancer.
Where can I participate?
CS Cancer at The Angeles Clinic and Research Institute
More about this Clinical Trial
What is the full name of this clinical trial?
An Open-Label Phase 1 Study To Investigate PF-08046031 in Adults with Advanced Melanoma and other Solid Tumors