RecruitingPhase 1NCT06131840

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

An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

914 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasms

Summary

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. Participants in this study must have cancer that has come back or did not get better with treatment. Participants 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 has 5 different study 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. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new antibody-drug combination (SGN-CEACAM5C) that targets a protein called CEACAM5, which is overproduced by several types of cancer. The drug delivers a cell-killing agent directly to cancer cells expressing this protein. The study is open to people with advanced colorectal, stomach/esophageal junction, lung, pancreatic, and small cell lung cancers. **You may be eligible if...** - You are 18 or older with advanced colorectal, gastric, lung, or pancreatic cancer - Your cancer has progressed after standard treatments - Your cancer is measurable on imaging - Your general health status is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously been treated with a CEACAM5-targeted therapy or a TOPO1 drug (such as trastuzumab deruxtecan or sacituzumab govitecan) - You have another cancer diagnosed within 3 years - You have active brain involvement by your cancer - You have a recent serious blood clot or bleeding disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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