Dose escalation/expansion trial with BYON4228 alone and in combination in metastatic solid tumors

• Research type

  Research Study

• Full title

  A dose escalation and expansion trial with the SIRPα-directed monoclonal antibody BYON4228 alone and in combination to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with advanced or metastatic solid tumors

• IRAS ID

  1011283

• Contact name

  Evelyn van den Tweel

• Contact email

  clinicaltrials@byondis.com

• Sponsor organisation

  Byondis B.V.

• Research summary

  This is a phase 1 dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BYON4228, alone and in combination, in participants with solid tumours.
  BYON4228 is an experimental drug given via infusion during the course of this study. Other procedures include infusion of Pembrolizumab, vital signs, blood samples and tumour assessments (including CT Scans),

  Participants will be enrolled in two stages: a dose-escalation stage (Part 1) and an expansion stage (Part 2).

  The dose escalation part of the trial (Part 1) will include participants with solid tumors of any origin that has not improved with standard therapy or for whom a standard therapy does not exist.
  The expansion part of the trial (Part 2), will include participants with skin cancer (melanoma) that has not improved with standard therapy or for whom a standard therapy does not exist. They will be enrolled in Cohort A. Participants with other solid tumour types will be enrolled into Cohort B.

• REC name

  London - Central Research Ethics Committee

• REC reference

  25/LO/0069

• Date of REC Opinion

  11 Mar 2025

• REC opinion

  Further Information Favourable Opinion