BP42233 - Phase 1 Study of the Safety of RO7425781 in Multiple Myeloma

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, MULTICENTER, PHASE I STUDY EVALUATING THE SAFETY AND PHARMACOKINETICS OF ESCALATING DOSES OF RO7428751 IN PARTICIPANTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

• IRAS ID

  1003492

• Contact name

  Rakesh Popat

• Contact email

  rakesh.popat@ucl.ac.uk

• Eudract number

  2020-002012-46

• Research summary

  This study is a first in human, open-label, uncontrolled, multicenter, dose-escalation and expansion Phase I study, which is
  designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of RO7425781 in patients with
  relapsed or refractory multiple myeloma for whom no standard-of-care treatment exists or who are intolerant to those established
  therapies.
  RO7425781 belongs to a group of medicines called cancer immunotherapy. It is designed to help the body kill tumour cells. It
  does this by activating the immune system, in particular, T cells (a type of immune cells) against the tumour. Evidence suggests
  that T cell-mediated killing of multiple myeloma cells can result in clinical benefit.
  Part 1 of the study is a “dose escalation” of RO7425781. Participants in one group will receive RO7425781 at a certain dose
  and once this dose is considered safe, the next group of participants will receive a higher dose. Some participants will receive
  RO7425781 as an intravenous infusion whereas other participants will receive RO7425781 as a subcutaneous injection.
  Part 2 of the study is the “extension” because the study will be extended to include larger groups of participants. The dose of
  RO7425781 will be the same for all participants in Part 2. This dose level will be based on the findings from Part 1.
  Approximately 12 participants will take part in the study in the UK and 240 worldwide.
  The study duration per participant from screening until safety follow-up visit will be approximately 69 weeks (not including followup)
  and includes:
  -Screening
  -Treatment period: Up to one year, or until disease progression, consent withdrawal,
  unacceptable toxicity, or death, whichever occurs first
  -Follow-up

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0409

• Date of REC Opinion

  15 Jan 2021

• REC opinion

  Further Information Favourable Opinion