Phase 1/2 Study of BT7480 in Patients with Advanced Cancer
Research type
Research Study
Full title
Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies
IRAS ID
304351
Contact name
Amy Dickson
Contact email
Sponsor organisation
BicycleTx Limited
Eudract number
2021-004468-80
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND 153518 , IND Number
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
This study will be a Phase 1/2, first-in-human, open label, dose escalation, dose confirmation, and dose expansion multicenter study to evaluate the safety, PK, and clinical activity of BT7480 in patients with advanced solid tumors associated with Nectin-4 expression.
BT7480 is a new generation synthetic Nectin-4 targeted CD137 agonist. Nectin-4 is highly expressed by numerous tumors with unmet medical need, including bladder, pancreas, breast, ovary, oesophagus, head and neck, stomach, and lung cancers. Many of these tumor types also contain CD137 expressing cells. BT7480 has the potential to be an effective anticancer therapy with a wide safety margin since it can diffuse and penetrate tumors very rapidly yet spare peripheral normal tissues due to its short terminal half-life (t½), renal elimination, and tumor-targeted immune response.
BT7480 binds to both Nectin-4 and CD137 and may activate the immune cells to fight the Nectin-4-expressing cancers. This study is designed to evaluate whether, and at which dose, BT7480 will be a well tolerated and effective anticancer therapy. The entire study will enroll a total of approximately 200 patients.
REC name
West of Scotland REC 1
REC reference
22/WS/0004
Date of REC Opinion
14 Mar 2022
REC opinion
Further Information Favourable Opinion