Bicycle Tx BT5528-100

• Research type

  Research Study

• Full title

  Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression

• IRAS ID

  287955

• Contact name

  Louise Carter

• Contact email

  Louise.Carter@christie.nhs.uk

• Sponsor organisation

  Bicycle Tx Limited

• Eudract number

  2019-003653-29

• Clinicaltrials.gov Identifier

  NCT04180371

• Clinicaltrials.gov Identifier

  2019-003653-29, N/A

• Duration of Study in the UK

  3 years, 8 months, 0 days

• Research summary

  The primary objectives of the escalation (Parts A-1 and A-2) are:
  • To assess safety and tolerability of BT5528 in patients with advanced solid tumor malignancies associated with EphA2-expression and/or specified tumors identified as positive for EphA2 tumor expression as a monotherapy (Part A-1) and in combination with nivolumab (Part A-2)
  • To define the maximum tolerated dose (MTD) of BT5528, if observed, and determine a recommended Phase II dose (RP2D) as a monotherapy (Part A-1) and in combination with nivolumab (Part A-2).

  The primary objectives of the expansions (Parts B-1 and B-2) are:
  • To assess the clinical activity of BT5528 in patients with selected adenocarcinoma non small cell lung cancer (NSCLC) identified as positive for EphA2 tumor expression as a monotherapy (Part B-1) and in combination with nivolumab (Part B-2) using RECIST 1.1

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0328

• Date of REC Opinion

  9 Oct 2020

• REC opinion

  Further Information Favourable Opinion