BicycleTx BT8009-100
Research type
Research Study
Full title
BT8009-100: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
IRAS ID
285566
Contact name
Louise Carter
Contact email
Sponsor organisation
BicycleTx Ltd.
Eudract number
2020-002719-23
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 9 months, 23 days
Research summary
The primary objectives of the escalation and renal cohorts (Parts A-1, A-2, Part C) are to assess safety and tolerability of BT8009 in patients with advanced solid tumor malignancies associated with Nectin-4 expression as a monotherapy (Part A-1) or in combination with nivolumab (Part A-2) or in patients with advanced solid tumor malignancies having renal insufficiency (Part C). Define the maximum tolerated dose of BT8009, if observed, and determine a recommended Phase II dose (RP2D) as a monotherapy and in combination with nivolumab (Parts A-1 and A-2).
The primary objective of the expansion cohort (Parts B-1 and B-2) is to assess the clinical activity of BT8009 in patients with solid tumor indications associated with Nectin-4 expression as a monotherapy (Part B-1) and in combination with nivolumab (Part B-2) using RECIST 1.1.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0247
Date of REC Opinion
29 Oct 2020
REC opinion
Favourable Opinion