A Safety Study of SGN-35T in Adults with Advanced Cancers
Research type
Research Study
Full title
An open-label phase 1 study to evaluate the safety of SGN-35T in adults with advanced malignancies
IRAS ID
1008781
Contact name
Tara Chen
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2022-502390-41
Clinicaltrials.gov Identifier
Research summary
We are doing this study to learn more about the safety of the study drug SGN-35T. We also want to see if it works to treat different kinds of lymphoma. This study will enroll patients who have certain types of Hodgkin or Non-Hodgkin lymphoma that have come back or did not get better with the last treatment. We do not know if SGN‑35T will work to treat cancer. This study is the first time SGN‑35T is being given to people. It may be a new treatment option, or there may be no benefit to patients.
SGN-35T 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-cancer cells in the body.
This study will be done in 3 parts: Parts A and B will test different doses and how often the study drug should be given. Part C will use the information found in Parts A and B to test if SGN-35T is safe and works in different types of cancers. All patients in this study will get SGN-35T over a 3-week period called “a cycle”. 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-35T. We also want to find the best dose for the study drug.
We will do a PET scan, and MRI or CT scan to look for signs of cancer at the start of the study. We will also do a scan for all patients at the end of Cycle 2, and every 3 months after Cycle 2 to find out if the cancer stayed the same, got better, or got worse after patients were given SGN-35T.
REC name
West of Scotland REC 1
REC reference
24/WS/0017
Date of REC Opinion
4 Mar 2024
REC opinion
Further Information Favourable Opinion