A Study of SGN-CEACAM5C in adults with advanced solid tumors
Research type
Research Study
Full title
An open-label phase 1 study to investigate SGN-CEACAM5C in adults with advanced solid tumors
IRAS ID
1009317
Contact name
Suzanne McGoldrick
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2023-505858-18
Research summary
This is a phase 1, open-label, multicentre study designed to test the safety, tolerability, and anti-tumour activity of the drug SGN-CEACAM5C in adults with various types of solid tumours (Gastric cancer, gastro-oesophageal junction adenocarcinoma, small cell lung cancer, non-small cell lung cancer both squamous and non-squamous, colorectal cancer and pancreatic ductal adenocarcinonma). There will be multiple parts of the study which test for different aspects of this. Up to 410 participants will be enrolled onto the trial globally, with approximately 40 participants expected to take part in the UK. We do not know if SGN-CEACAMC will work to treat cancer, and this is the first time this drug has been given to people. It may be a new treatment option, or there may be no benefit to participants.
SGN-CEACAM5C is a type of drug called an antibody-drug conjugate or ADC. It is designed to stick to cancer cells and kill them. It may also stick to some non-cancerous cells in the body which may cause side effects. All participants will receive SGN-CEACAM5C as an intravenous infusion, initially once over a three week period called a “cycle” – changing as necessary through the course of the study. We will measure the side effects of the study drug, how often they happen, and how serious they are. We will decide if the side effects are caused by SGN-CEACAM5C. We also want to find the best dose for the study drug.
The study will be done in 3 parts: Parts A and B will test the different doses and how often the study drug should be given. Parts A will recruit around 90 participants and Part B will recruit around 80 participants. Part C will use the information found in Parts A and B to test the drug on specific tumour types. Part C will recruit around 240 participants.
REC name
Wales REC 2
REC reference
24/WA/0072
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Favourable Opinion