What is the Purpose of this Study?
Primary -To characterize the safety and tolerability profile of PF-08046031 in participants with advanced melanomas and select solid tumors (Parts 1, 2, 3) -To identify the MTD or MAD of PF-08046031 (Part 1) -To identify a recommended dose for expansion and schedule of PF-08046031 (Parts 1, 2, 3) Secondary -To characterize the PK of PF-08046031 (Part 1, 2, 3) -To characterize the immunogenicity of PF-08046031 (Part 1, 2, 3) -To determine the preliminary antitumor activity of PF-08046031 (Parts 1, 2, 3)
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