An open-label phase 1 study to investigate PF-08046050 (SGN-CEACAM5C) in adults with advanced solid tumors

Primary Objective

This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells. This study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. This study will have 3 parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers.

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Description

This study plans to learn more about the investigational drug PF-0804650 to find out what its side effects are and if it works for solid tumor cancer. A side effect is anything the drug does to your body besides treating your disease. If you have side effects, your study doctor may prescribe or give you medicine to help you with your symptoms. We also want to know if the study drug PF0804650works for solid tumors that have come back or didn’t get better with your last treatment. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). You are being asked to be in this research study because you have a solid tumor cancer. Your solid tumor cancer can’t be treated with the drugs most often used for that kind of cancer. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Your cancer may have spread to other parts of your body, which is called metastatic. Or it may not be easy to remove through surgery, which is called unresectable. Your cancer may have come back after treatment, or not gotten better since your treatment. These types of cancer are harder to treat. You must have 1 of the following types of cancer to take part in this study: colon rectum stomach esophagus (a tube that runs from your throat to your stomach) lungs pancreas There are 3 parts to this study: Part A will test PF-0804650to find the best amount of drug to give people and how often to give it. We also want to find out what side effects PF-0804650 may cause. Part B will use the information we learned in Part A to keep studying the best amount of drug and how often to give it to people. We’ll also check for any side effects. Part C will use what we learned in Part A and Part B to test how well PF-0804650works to treat some types of solid tumor cancers. We’ll check for side effects in Part C too. Your doctor will tell you which part of the study you will be in

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Sarah Davis

Sarah Davis

Study ID

Protocol Number: 23-2329

More information available at ClinicalTrials.gov: NCT06131840

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