A study of SGN-BB228 in advanced melanoma and other solid tumors
Research type
Research Study
Full title
A phase 1 study of SGN-BB228 in advanced melanoma and other solid tumors
IRAS ID
1007351
Contact name
Juan Pinelli
Contact email
Sponsor organisation
Seagen Inc
Eudract number
2022-502348-11
Clinicaltrials.gov Identifier
Research summary
SGN-BB228 is a type of drug called an Antibody-Anticalin fusion bispecific. Bispecific means that the drug has two main parts. The antibody part sticks to cancerous cells – and the anticalin part sticks to immune system cells and helps them to attack cancer cells.
In this Phase 1 trial we will study advanced melanoma skin cancer and there are three parts. Part A will test different doses (dose escalation) to see how safe it is. In Part B, information from Part A will be used to find the best dose and schedule for giving SGN-BB228. In Part C we’ll test how it works to treat melanoma as well as other cancers (non-small cell lung cancer, colorectal (bowel) cancer, pancreatic cancer, and mesothelioma). Participants may be enrolled in either Part A, Part B, or Part C.
Participants enroled to Part A will receive the study drug through an intravenous (IV) infusion over a 28-day period of time, called a cycle. They will receive the study drug twice during this 28-day cycle. Participants enrolled to Part B may receive the drug on that schedule, or one that uses a 21-day cycle. This will help us understand which schedule might be better. Participants in Part C will be enroled onto either the 28 day cycle or the 21 day cycle depending on the results of Parts A and B. At the end of a cycle, participants may go on to complete further cycles, or they may come off the trial. Participants have scans every 6 weeks to check whether the cancer has changed. Their doctor will review these scans and explain the results.
Approximately 275 participants will enrol onto this trial worldwide. This includes 45 participants for Part A, 30 subjects for Part B, and approximately 200 subjects in Part C.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0353
Date of REC Opinion
26 Jul 2023
REC opinion
Further Information Favourable Opinion