Phase 1 Study of PF-08046050 SGN-CEACAM5C in Adults With Advanced or Metastatic Solid Tumors Not Responsive to Standard Treatments

What this Trial Is About

This clinical trial is studying adults with advanced solid tumors, which are cancers that start in a solid part of the body like the lungs or liver and have either grown large, spread to other areas, or cannot be removed by surgery. The study focuses on cancers that have returned or did not improve with previous treatments and are difficult to treat because standard drugs are not effective. The trial aims to evaluate the safety of a new experimental drug called PF-08046050, an antibody-drug conjugate designed to target and kill cancer cells. The study includes five parts Parts A and B determine the appropriate dose of PF-08046050 given alone. Part C uses this information to assess safety and effectiveness in certain solid tumors. Parts D and E explore the doses and safety of PF-08046050 combined with other cancer drugs such as bevacizumab, 5-Fluorouracil 5-FU, leucovorin, and oxaliplatin. The drug and combinations are given intravenously, and participants receive different treatment regimens depending on the study part. Participants will be monitored throughout the study and up to about two years after their last treatment. Assessments include tracking side effects, lab test abnormalities, dose changes caused by side effects, and dose-limiting toxicities within the first 28 days. Researchers will also measure how the drug moves through the body, immune responses, and cancer progression or response using imaging criteria. Safety and overall survival will be followed closely during and after treatment, with regular visits and evaluations scheduled as part of the trial.

A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors