BP44474 A Phase I study of RO7589831 in advanced solid tumours

• Research type

  Research Study

• Full title

  A PHASE I, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF RO7589831 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS HARBORING MICROSATELLITE INSTABILITY (MSI) AND/OR DEFICIENT MISMATCH REPAIR (DMMR)

• IRAS ID

  1008356

• Contact name

  Amandeep Bajwa

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  2023-503170-20

• Research summary

  We are investigating a new drug to treat cancers that have a mutation that causes a defect in repairing DNA (called deficient Mismatch Repair-dMMR). This defect in repairing DNA leads to a specific type of DNA change in the cancer cells (called Microsatellite instability-MSI). The cancer cells with this DNA modification need a protein called Werner helicase to repair their DNA, in order for them to survive.
  40% to 70% of MSI and/or dMMR tumours do not respond or develop secondary resistance to approved treatments, and the use of these treatments can be limited by side effects. Therefore, novel therapies are needed for patients with MSI and/or dMMR tumours.
  RO7589831 has been developed to specifically block the activity of the Werner helicase protein, which is expected to lead to the death of these cancer. This is an early phase clinical trial and will be the first time that this study treatment will be given to humans.
  The purpose of this study is to find out whether RO7589831 at different dose(s) has any effects, what happens to the RO7589831 once it is in the body, and what the study treatment does to the body and the development of the cancer.
  Approximately 15 participants, across 2 hospitals in the UK. Globally 220 participants will take part.
  The study will consist of different 4 Parts and which part of the study each participant will participate in will depend on when they are enrolled and their type of cancer. All participants will receive RO7589831 but different groups may receive different doses.
  Patients with a solid tumour that has MSI and/or dMMR will be eligible for this study.
  The total time in the study will depend on how the patient’s cancer responds to the study treatment.
  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version 1 29 Jun 2023

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  23/LO/0795

• Date of REC Opinion

  29 Nov 2023

• REC opinion

  Further Information Favourable Opinion