A Study of SGN-EGFRd2 in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors
IRAS ID
1008649
Contact name
Corinna Palanca-Wessels
Contact email
Sponsor organisation
Seagen Inc
Eudract number
2023-505848-19
Clinicaltrials.gov Identifier
Research summary
This trial is called A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors. This trial tests an experimental drug called SGN-EGFRd2 to determine its effectiveness against different types of cancer. The trial will recruit approximately 275 participants worldwide who have one of four cancers: bowel cancer, non-small cell lung cancer, head and neck cancer, and pancreatic cancer.
There are three parts to this trial, labelled A, B, and C. Participants will enrol onto one part. Part A aims to find the best dose with the fewest side effects; Part B further researches the best dose and also investigates the best schedule for dosing; and Part C investigates the anti-tumour effects of the drug.
After screening, participants who qualify to be on the trial will begin study visits. SGN-EGFRd2 will be given to participants on a schedule called a cycle. Each cycle will last 3 or 4 weeks, which means that participants could get the drug once every 2 weeks for 4 weeks (4 week cycle), one a week for 3 weeks (3 week cycle), or once every 3 weeks (a 3 week cycle). Some participants may also have a 1-week cycle before starting the regular cycles. Participants will be monitored for up to 16 hours after the first dose of the study drug to make sure they are OK, which could mean an overnight stay. Following the first dose, the monitoring time will be much shorter.
Participants undergo various tests including tumour biopsies (Taking a sample of the tumour for analysis), blood sampling, and scans to check the effects of the drug on their cancer.
Participants will have follow-up visits every three months after they have stopped taking the drug, and the trial will be closed three years after the last participant gets their last dose of study drug.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0253
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion